Wrap, Sterilization
FDA product code FRG · Class II (moderate risk) · 21 CFR 880.6850 · General Hospital
323510(k) clearances
0PMA approvals
50recalls
Manufacturers
- Kimberly-Clark Corp. 11
- Medline Industries, LP 11
- Cardinal Health200, LLC 11
- Case Medical, Inc. 9
- STERIS Corporation 8
- Custom Pack Reliability 7
- Wipak OY 7
- Andersen Sterilizers, Inc. 6
- Aesculap, Inc. 6
- Cush Medical Products 6
- Surgicot, Inc. 5
- Allegiance Healthcare Corp. 5
- Clinical Resources, Inc. 5
- Kimberly-Clark Health Care 5
- Sigma Medical Supplies Corp. 5
- Medicare Industries, Inc. 4
- Associated Medical Products Co. 4
- Turbett Surgical, Inc. 4
- Contour Fabricators of Florida, Inc. 4
- GE Medical Systems, LLC 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional | O&M Halyard, Inc. | 07/02/2026SE |
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | Dukal, LLC | 05/28/2026SE |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 05/18/2026SE |
| K251347 | Sterilization Pouch/RollFRG · Traditional | Sterivic Medical Co., Ltd. | 01/28/2026SE |
| K251177 | Self-Seal Sterilization Pouch and RollFRG · Traditional | Guangdong Maidi Medical Co., Ltd. | 12/12/2025SE |
| K250306 | Chex-All Sterilization Pouches and TubesFRG · Abbreviated | Propper Manufacturing Co., Inc. | 10/31/2025SE |
| K243179 | Sterilization Pouch and RollFRG · Traditional | Yichang Xinxin Paper Products Co., Ltd. | 06/26/2025SE |
| K250321 | GCI Sterilization WrappersFRG · Traditional | George Courey, Inc. | 06/06/2025SE |
| K243721 | Self Sealing Sterilization PouchesFRG · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 04/25/2025SE |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional | Turbett Surgical | 04/04/2025SE |
| K241565 | Sterilization Package/ReelFRG · Traditional | Anqing Clean Dental Instrument Technology Co.… | 02/24/2025SE |
| K243431 | Medicom Sterilization Pouch and ReelFRG · Traditional | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 02/21/2025SE |
| K242898 | Sterilization Pouches and ReelsFRG · Traditional | Shanghai Jianzhong Medical Packaging Co., Ltd. | 02/21/2025SE |
| K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)FRG · Traditional | Comercializadora Brever | 11/04/2024SE |
| K242839 | Safe Secure Sterilization Pouches and RollsFRG · Traditional | Shenzhen Safesecure Medical Infection Control… | 10/16/2024SE |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | Primed Medical Products, Inc. | 10/07/2024SE |
| K241123 | Perpak Sterilization Tyvek PouchFRG · Traditional | Km Corp. | 09/18/2024SE |
| K234132 | Medline Reusable Sterilization WrappersFRG · Traditional | Medline Industries, LP | 09/17/2024SE |
| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 09/16/2024SE |
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 08/07/2024SE |
| K240862 | Medicom Sterilization WrapFRG · Traditional | Medicom Group, Inc. | 06/21/2024SE |
| K232625 | Steriking® Pouch for Robotic InstrumentsFRG · Traditional | Wipak OY | 06/07/2024SE |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | Primed Medical Products, Inc. | 05/24/2024SE |
| K233262 | Dukal SMS Sterilization WrapFRG · Traditional | Dukal, LLC | 03/22/2024SE |
| K230137 | Reliance® Fusion Sterilization WrapsFRG · Traditional | Ahlstrom-Munksjo Nonwovens, LLC | 12/07/2023SE |
| K231999 | Steriking® LT-Blueline Pouches with Tyvek®FRG · Special | Wipak OY | 09/07/2023SE |
| K231996 | Steriking® LT-Blueline Pouches with Tyvek®FRG · Special | Wipak OY | 09/07/2023SE |
| K223600 | Sterilization WrapFRG · Traditional | Wuhan Zonsen Medical Products Co., Ltd. | 08/25/2023SE |
| K231500 | Vis-U-All Low Temperature Sterilization PouchesFRG · Traditional | STERIS Corporation | 08/07/2023SE |
| K223025 | Tyvek Roll with CI for STERLINK SterilizerFRG · Traditional | Plasmapp Co,., Ltd. | 05/09/2023SE |
| K222151 | Sterilization WrapFRG · Traditional | Kenpax International Limited | 03/23/2023SE |
| K221875 | Sterilization Pouch and RollFRG · Traditional | Qianjiang Kingphar Medical Packaging & Printing… | 02/13/2023SE |
| K221379 | Steriking LT-Blueline Pouches with TyvekFRG · Traditional | Wipak OY | 01/04/2023SE |
| K221377 | SteriKing LT-Blueline Pouches with TyvekFRG · Traditional | Wipak OY | 12/22/2022SE |
| K220365 | Gemini Sterilization WrapFRG · Traditional | Medline Industries, LP | 10/06/2022SE |
| K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysFRG · Special | Steris | 09/09/2022SE |
| K191131 | Solidence MultipocketsFRG · Traditional | Solidence Surgical Corporation | 08/03/2022SE |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapFRG · Traditional | Owens & Minor (O&M) Halyard, Inc. | 07/27/2022SE |
| K221016 | Steriking Packaging for Medical DevicesFRG · Special | Wipak OY | 05/05/2022SE |
| K213907 | CareGUARD Sterilization WrapFRG · Traditional | Care Essentials Pty, Ltd. | 03/14/2022SE |
| K220133 | Sterilization WrapsFRG · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 03/10/2022SE |
| K210810 | Steiking Packaging for Medical DevicesFRG · Traditional | Wipak OY | 01/23/2022SE |
| K212338 | SterileRight sterilization pouch and rollFRG · Traditional | Sterileright Packaging Mfg., Inc. | 11/01/2021SE |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM SterilizerFRG · Traditional | Plasmapp Co,., Ltd. | 10/22/2021SE |
| K202593 | Turbett Instrument PodFRG · Traditional | Turbett Surgical, Inc. | 05/19/2021SE |
| K202462 | SIGMA Sterilization Pouch and RollFRG · Abbreviated | Sigma Medical Supplies Corporation | 04/23/2021SE |
| K200336 | Tyvek Sterilization Pouches with Chevron SealFRG · Traditional | Andersen Sterilizers, Inc. | 11/12/2020SE |
| K200335 | Sterisheet Sterilization WrapFRG · Traditional | Andersen Sterilizers, Inc. | 11/12/2020SE |
| K200240 | Turbett Instrument PodFRG · Traditional | Turbett Surgical, Inc. | 04/30/2020SE |
| K193561 | Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device…FRG · Special | Weihai Xingtai Packaging Products Co., Ltd. | 04/15/2020SE |
| K192641 | Gemini Titan Sterilization WrapFRG · Traditional | Medline Industries, Inc. | 01/24/2020SE |
| K192147 | Halyard ONE-STEP* Sterilization WrapFRG · Traditional | Owens & Minor (O&M) Halyard, Inc. | 10/10/2019SE |
| K182184 | Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch…FRG · Traditional | Mdk (Shanghai) Medical Packing Co., Ltd. | 10/10/2019SE |
| K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device…FRG · Traditional | Weihai Xingtai Packaging Products Co., Ltd. | 08/19/2019SE |
| K181957 | Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat…FRG · Traditional | Tianchang Jiarui Packaging Material Co., Ltd. | 07/09/2019SE |
| K182656 | JAMBRO Single Core A Sterilization wrapFRG · Traditional | Jiangsu Zhande Medical Supplies Co., Ltd. | 06/11/2019SE |
| K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)FRG · Traditional | Owens & Minor Halyard, Inc. | 03/22/2019SE |
| K183401 | Vis-U-All Low Temperature Sterilization Pouch/TubingFRG · Traditional | STERIS Corporation | 03/01/2019SE |
| K183297 | Vis-U-All Low Temperature Sterilization Pouch/TubingFRG · Traditional | STERIS Corporation | 01/03/2019SE |
| K180139 | Safe Secure Sterilization Pouches and RollsFRG · Traditional | Safe Secure Packing Co., Ltd. | 01/03/2019SE |
| K181174 | Cardinal Health Sterilization WrapFRG · Traditional | Cardinal Health200, LLC | 12/11/2018SE |
| K172280 | BH Sterilization PouchFRG · Traditional | Bh Medical Products Co., Ltd. | 08/03/2018SE |
| K180672 | Sterilization Pouch/Roll Made with TyvekFRG · Abbreviated | Sigma Medical Supplies Corporation | 06/06/2018SE |
| K180661 | SIGMA Sterilization Pouch and RollFRG · Abbreviated | Sigma Medical Supplies Corp. | 06/05/2018SE |
| K172749 | Vis-U-All Low Temperature Sterilization Pouch/TubingFRG · Traditional | STERIS Corporation | 02/09/2018SE |
| K170437 | Sterisheet Sterilization WrapFRG · Traditional | Andersen Sterilizers, Inc. | 11/01/2017SE |
| K170429 | Tyvek Sterilization Pouches with Chevron SealFRG · Traditional | Andersen Sterilizers, Inc. | 10/27/2017SE |
| K162362 | PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical IndicatorFRG · Traditional | Pms Tibbi Cihazlar Teknolojisi San VE Tic AS | 10/13/2017SE |
| K172207 | Standard Supreme Sterilization WrapperFRG · Traditional | Standard Textile Co., Inc. | 08/25/2017SE |
| K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapFRG · Traditional | Ahlstrom Nonwovens, LLC | 06/29/2017SE |
| K162993 | Gemini Sterilization WrapFRG · Traditional | Medline Industries, Inc. | 06/23/2017SE |
| K162258 | Self Sealing Sterilization PouchesFRG · Traditional | Tianchang Jiarui Packaging Material Co., Ltd. | 04/28/2017SE |
| K161910 | Cardinal Health Sterilization WrapFRG · Traditional | Cardinal Health200, LLC | 04/20/2017SE |
| K161415 | SteriTite Containers System & MediTray ProductsFRG · Traditional | Case Medical, Inc. | 02/10/2017SE |
| K160595 | PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorFRG · Traditional | Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti | 11/18/2016SE |
| K162162 | Barrier Supreme Sterilization WrapperFRG · Traditional | Standard Textile Co., Inc. | 11/04/2016SE |
| K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsFRG · Traditional | Safe Secure Packaging Co., Ltd. | 08/04/2016SE |
| K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapFRG · Traditional | Ahlstrom Nonwovens, LLC | 07/27/2016SE |
| K160908 | Vis-U-All Low Temperature Sterilization Pouch/TubingFRG · Traditional | STERIS Corporation | 07/22/2016SE |
| K152564 | Gemini Sterilization WrapFRG · Traditional | Medline Industries, Inc. | 07/07/2016SE |
| K152458 | Gemini Bonded Sterilization WrapFRG · Traditional | Medline Industries, Inc. | 06/01/2016SE |
| K152669 | PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)FRG · Traditional | Pms Tip Teknolojileri Sanayi VE Ticaret Limited… | 01/15/2016SE |
| K153025 | Turbett Surgical ContainerFRG · Traditional | Turbett Surgical, LLC | 01/14/2016SE |
| K151445 | Cardinal Health Sterilization WrapFRG · Traditional | Cardinal Health200, LLC | 12/21/2015SE |
| K152291 | Sterisheet Sterilization WrapFRG · Traditional | Andersen Sterilizers, Inc. | 12/17/2015SE |
| K150698 | Gemini Sterilization WrapFRG · Traditional | Medline Industries, Inc. | 11/20/2015SE |
| K152058 | Tyvek Sterilization Pouches with Chevron SealFRG · Traditional | Andersen Sterilizers, Inc. | 11/18/2015SE |
| K151788 | Cardinal Health Sterilization WrapFRG · Traditional | Cardinal Health200, LLC | 10/30/2015SE |
| K143117 | Wire Sterilization Package with IndicatorsFRG · Traditional | American Orthodontics | 10/29/2015SE |
| K143637 | U&U Sterilization Pouch and RollFRG · Traditional | U&U Medical Technology Co, Ltd. | 09/09/2015SE |
| K143147 | Gemini Bonded Sterilization WrapFRG · Special | Medline Industries, Inc. | 05/07/2015SE |
| K143053 | KIMGUARD ONE-STEP Sterilization WrapFRG · Traditional | Kimberly-Clark Health Care | 04/03/2015SE |
| K141826 | Flashpak Sterilization Container SystemFRG · Traditional | Symmetry Medical Inc- Manchester | 04/02/2015SE |
| K133838 | Sterilization Pouch/Roll Made with TyvekFRG · Traditional | Sigma Medical Supplies Corp. | 03/11/2015SE |
| K142782 | KIMGUARD ONE-STEP Sterilization WrapFRG · Traditional | Kimberly-Clark Health Care | 03/09/2015SE |
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorFRG · Traditional | Advanced Sterilization Products | 12/19/2014SE |
| K141712 | Kimguard One Step Sterilization WrapFRG · Traditional | Halyard Health | 12/18/2014SE |
| K141412 | Sterilucent Self-Seal Sterilization PouchFRG · Traditional | Gs Medical Packaging, Inc. | 12/03/2014SE |
| K140963 | Kimguard Smart-Fold Sterilization WrapFRG · Traditional | Kimberly-Clark Corp. | 11/10/2014SE |
| K141612 | Kimguard One-Step Sterilization WrapFRG · Special | Kimberly-Clark Health Care | 08/07/2014SE |
| K141071 | Kimguard One-Step Sterilization WrapFRG · Traditional | Kimberly-Clark Health Care | 07/28/2014SE |
| K140487 | Vis-U-All Low Temperature Sterilization Pouch/TubingFRG · Traditional | STERIS Corporation | 07/22/2014SE |
| K123162 | U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollFRG · Traditional | U&U Medical Technology Co, Ltd. | 02/26/2014SE |
| K132060 | Durablue Sterilization WrapFRG · Traditional | Cardinal Health-Medical Products and Services | 12/13/2013SE |
| K113806 | Kimguard One Step Sterilization WrapFRG · Traditional | Kimberly-Clark Health Care | 08/20/2013SE |
| K130927 | Durablue Sterilization WrapFRG · Special | Cardinal Health200, LLC | 06/18/2013SE |
| K123289 | Durablue Sterilization WrapFRG · Traditional | Cardinal Health-Medical Products and Services | 02/28/2013SE |
| K113353 | Gemini Sterilzation WrapFRG · Traditional | Medline Industries, Inc. | 01/31/2013SE |
| K123857 | Durablue Sterilization WrapFRG · Traditional | Cardinal Health200, LLC | 01/23/2013SE |
| K122507 | Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600…FRG · Traditional | Cardinal Health200, LLC | 09/26/2012SE |
| K110954 | Arjorad Sterile WrapFRG · Traditional | Arjo Wiggins Medical, Inc. | 08/24/2012SE |
| K113776 | FlashpakFRG · Traditional | Symmetry Medical | 08/08/2012SE |
| K112805 | Kimguard One-Step Sterilization WrapFRG · Traditional | Kimberly-Clark Corp. | 06/22/2012SE |
| K120658 | Durablue Sterilization WrapFRG · Traditional | Cardinal Health200, LLC | 06/13/2012SE |
| K120542 | Cardinal Health Durablue Sterilization WrapFRG · Traditional | Cardinal Health-Medical Products and Services | 06/01/2012SE |
| K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsFRG · Traditional | Safe Secure Packaging Co., Ltd. | 02/07/2012SE |
| K112904 | Steritec Containers System & Meditray ProductsFRG · Traditional | Case Medical, Inc. | 01/24/2012SE |
| K112918 | Durablue Sterilization (Amsco V-Pro) WrapFRG · Traditional | Cardinal Health200, LLC | 01/20/2012SE |
| K112300 | Kimguard Smart-Fold* Sterilization WrapFRG · Special | Kimberly-Clark Corp. | 01/19/2012SE |
| K112283 | Dura Blue Sterilization WrapFRG · Traditional | Cardinal Health200, LLC | 10/20/2011SE |
| K112211 | Dura Blue Sterilization WrapFRG · Traditional | Cardinal Health200, LLC | 10/20/2011SE |
| K102158 | Sigma Sterilization Pouch & RollFRG · Traditional | Sigma Medical Supplies Corp. | 08/02/2011SE |
| K110867 | Steri-Dent, Steri-SureFRG · Traditional | Cpac, Inc. | 07/20/2011SE |
| K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…FRG · Traditional | Advanced Sterilization Products | 06/06/2011SE |
| K102864 | 84E Series Single Ply WrapperFRG · Traditional | Lac Mac, Ltd. | 01/14/2011SE |
| K102783 | Hinson & Hale Medical Technologies Infused (R) Polyester WrappersFRG · Traditional | Hinson and Hale Medical Technologies, Inc. | 12/22/2010SE |
| K093493 | Aesculap Sterilcontainer SFRG · Traditional | Aesculap, Inc. | 07/27/2010SE |
| K093649 | Aesculap Sterilcontainer SFRG · Traditional | Aesculap | 05/11/2010SE |
| K090068 | Steritite Universal Container System and Meditray ProductsFRG · Traditional | Case Medical, Inc. | 02/24/2010SE |
| K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600FRG · Traditional | Kimberly-Clark Corp. | 11/02/2009SE |
| K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600FRG · Traditional | Kimberly-Clark Corp. | 09/03/2009SE |
| K082554 | Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600FRG · Traditional | Kimberly-Clark Corp. | 05/01/2009SE |
| K082177 | Kimguard One-Step Sterilization WrapFRG · Traditional | Kimberly-Clark Corp. | 03/27/2009SE |
| K080558 | Steritite Container System & Meditray ProductsFRG · Traditional | Case Medical, Inc. | 12/05/2008SE |
| K080198 | TSO3 Ozone Sterilization WrapFRG · Traditional | Tso3, Inc. | 05/30/2008SE |
| K071886 | Self Seal Sterilization PouchFRG · Traditional | Shanghai Jianzhong Medical Packaging Co., Ltd. | 12/27/2007SE |
| K071087 | Vis-U-All II Heat-Seal Pouch and TubingFRG · Traditional | STERIS Corporation | 10/16/2007SE |
| K062704 | Sterilization Pouch with IndicatorsFRG · Traditional | Winner Industries (Shenzhen) Co., Ltd. | 06/08/2007SE |
| K062100 | Arjowrap 47/100 and 47/88FRG · Special | Arjo Wiggins Medical, Inc. | 12/05/2006SE |
| K062510 | Aesculap Sterilcontainer SystemFRG · Traditional | Aesculap | 11/17/2006SE |
| K052992 | Conmed Linvatec Instrument Sterilization TrayFRG · Traditional | Conmed Linvatec | 10/16/2006SE |
| K052665 | Granton Medical 121-135 C Self-Seal Sterilization PouchesFRG · Traditional | Granton Medical , Ltd. | 02/27/2006SE |
| K053389 | Aesculap Sterilcontainer SystemFRG · Traditional | Aesculap, Inc. | 02/15/2006SE |
| K041096 | Wagner Steriset Sterilization ContainerFRG · Traditional | Wagner GmbH | 06/03/2005SE |
| K041623 | Reusable Sterilcontainer Filter Model #JK090FRG · Traditional | Aesculap, Inc. | 12/13/2004SE |
| K040865 | Aesculap Sterrad 100S Compatable SterilcontainerFRG · Traditional | Aesculap | 12/06/2004SE |
| K042580 | Tidi Brand Sterilization WrapFRG · Traditional | Banta Healthcare Group, Ltd. | 11/17/2004SE |
| K040707 | Packaging Tray and ComponentsFRG · Special | Vygon Us, LLC | 04/16/2004SE |
| K022978 | Steritite Container with Flashtite Valve Plate(S) & Meditray ProductsFRG · Traditional | Case Medical, Inc. | 05/09/2003SE |
| K031022 | Protec-Top, Sterident, BentoFRG · Special | Ronpak, Inc. | 04/14/2003SE |
| K023614 | Steritite Rigid Reusable Sterilization Container SystemFRG · Traditional | Case Medical, Inc. | 04/07/2003SE |
| K023658 | Sterilization Cases and TraysFRG · Traditional | Carr Metal Products, Inc. | 03/25/2003SE |
| K030853 | Steritite Perforated Base Rigid Reusable Sterilization Container System with…FRG · Traditional | Case Medical, Inc. | 03/21/2003SE |
| K023025 | Self Seal Sterilization PouchFRG · Traditional | Granton Medical , Ltd. | 03/04/2003SE |
| K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument HolderFRG · Traditional | Advanced Sterilization Products | 08/28/2002SE |
| K012931 | Genesis Sterrad Compatible Reusable Sterilization Container SystemFRG · Traditional | Allegiance Healthcare Corp. | 08/20/2002SE |
| K013715 | Re-Usable Sterilization Pouch / BagFRG · Traditional | Quality Products of Montana | 04/01/2002SE |
| K993535 | Metapak Multi-Purpose Instrument TrayFRG · Traditional | Riley Medical, Inc. | 12/07/2001SE |
| K010825 | Medline Steriset Sterilization ContainerFRG · Traditional | Medline | 05/08/2001SE |
| K002968 | Medline Sterilization WrapFRG · Traditional | Medline Industries, Inc. | 01/23/2001SE |
| K983299 | Allegiance Genesis Container SystemFRG · Traditional | Allegiance Healthcare Corp. | 08/04/2000SE |
| K993871 | Bioshield Heavy Duty and Super Duty Express Sterilization WrapFRG · Traditional | Allegiance Healthcare Corp. | 04/21/2000SE |
| K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 -…FRG · Traditional | Case Medical, Inc. | 01/27/2000SE |
| K993835 | Parapost System Sterilizable OrganizerFRG · Traditional | Coltene/Whaledent, Inc. | 12/16/1999SE |
| K993255 | Biosonic UC-70 Sterilizable Instrument CassetteFRG · Traditional | Coltene/Whaledent, Inc. | 12/06/1999SE |
| K983719 | Bioshield Express Sterilization WrapFRG · Traditional | Allegiance Healthcare Corp. | 08/25/1999SE |
| K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteFRG · Traditional | Tuttnauer U.S.A Co, Ltd. | 07/09/1999SE |
| K990567 | Global Healthcare Self-Sealing Sterilization PouchFRG · Traditional | Global Healthcare, Inc. | 04/05/1999SE |
| K990300 | Suprashield Express Sterilization WrapFRG · Special | Allegiance Healthcare Corp. | 02/10/1999SE |
| K983223 | Dental Sterlization Tray/CassetteFRG · Traditional | Brasseler USA I, L.P. | 01/14/1999SE |
| K974638 | Steritite Sealed Containers Model SCO4QFRG · Traditional | Case Medical, Inc. | 12/18/1997SE |
| K972138 | Carr Rigid Container SystemFRG · Traditional | Carr Metal Products, Inc. | 11/13/1997SE |
| K971483 | Secure-Wrap (TM) Sterilization WrapFRG · Traditional | American Threshold Industries, Inc. | 06/24/1997SE |
| K964256 | Cygnus Instrument ProtectorsFRG · Traditional | Madison Polymeric Engineering | 05/06/1997SE |
| K962605 | Pro-Guard Double-Duty Sterilization Wrap (Single Use)FRG · Traditional | Surgicot, Inc. | 03/11/1997SE |
| K970152 | Biopsy TrayFRG · Traditional | Medcare Medical Group, Inc. | 03/05/1997SN |
| K961227 | JJ Skinner Carekits Wound Care Management/Dressing Change TrayFRG · Traditional | J.J. Skinner, Inc. | 06/10/1996SE |
| K960213 | CPR Total Hip PackFRG · Traditional | Custom Pack Reliability | 04/12/1996SE |
| K960211 | CPR Total Knee PackFRG · Traditional | Custom Pack Reliability | 04/12/1996SE |
| K960210 | CPR Ortho Hand PackFRG · Traditional | Custom Pack Reliability | 04/12/1996SE |
| K960206 | CPR Dressing Change TrayFRG · Traditional | Custom Pack Reliability | 04/12/1996SE |
| K960238 | CPR Suture Removal KitFRG · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K960208 | CPR Basic Set-Up TrayFRG · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K960520 | Laceration TrayFRG · Traditional | Medco Instruments, Inc. | 03/21/1996SE |
| K960207 | CPR Laceration TrayFRG · Traditional | Custom Pack Reliability | 02/27/1996SE |
| K960204 | G.E. Sterile, Percutaneous Cholangiographic TrayFRG · Traditional | GE Medical Systems | 02/27/1996SE |
| K960202 | G.E. Sterile Puncture TrayFRG · Traditional | GE Medical Systems | 02/21/1996SE |
| K960201 | G.E. Sterile Breast Biopsy/Localization TrayFRG · Traditional | GE Medical Systems | 02/21/1996SE |
| K960141 | G.E. Sterile, Standard Biopsy TrayFRG · Traditional | GE Medical Systems | 02/21/1996SE |
| K955688 | RNS Sterile, Disposable Standard Biopsy TrayFRG · Traditional | Contour Fabricators of Florida, Inc. | 02/21/1996SE |
| K955686 | RNS, Sterile Disposable Percutaneous Cholangiographic TrayFRG · Traditional | Contour Fabricators of Florida, Inc. | 02/21/1996SE |
| K955678 | RNS Sterile Disposable Puncture TrayFRG · Traditional | Contour Fabricators of Florida, Inc. | 02/21/1996SE |
| K955658 | Laceration TrayFRG · Traditional | Transidyne General Corp. | 01/25/1996SE |
| K953678 | Sterimed Sterization Wrapper (Non-Sterile)FRG · Traditional | Customed, Inc. | 10/02/1995SE |
| K951704 | Non-Woven Filter Paper for Steam and Gas SterilizationFRG · Traditional | Products For Medicine | 06/28/1995SE |
| K946019 | Surgicla Instrument KitFRG · Traditional | Medical Action Industries, Inc. | 03/20/1995SE |
| K950438 | Safedweel Dressing Change TrayFRG · Traditional | Becton Dickinson Vascular Access, Inc. | 03/15/1995SESK |
| K950850 | Gent-L-Kare Laceration TraysFRG · Traditional | Premium Plastics, Inc. | 03/14/1995SN |
| K943653 | Mammocore Biopsy TrayFRG · Traditional | Manan Medical Products, Inc. | 01/30/1995SEKD |
| K944881 | Skin Scrub TrayFRG · Traditional | Clinical Resources, Inc. | 12/27/1994SEKD |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1038-2023 Class II | Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that…Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments… | Turbett Surgical, Inc. | 12/05/2022Open, Classified |
| Z-1037-2023 Class II | Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that…Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments… | Turbett Surgical, Inc. | 12/05/2022Open, Classified |
| Z-1501-2022 Class II | Turbett Surgical Container, TS1500Devices were subject to unapproved rework processes. | Turbett Surgical, Inc. | 04/14/2022Terminated |
| Z-1111-2022 Class II | Turbett Surgical Container, TS1500Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after… | Turbett Surgical, LLC | 04/01/2022Open, Classified |
| Z-0799-2021 Class II | Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0798-2021 Class II | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0797-2021 Class II | Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0796-2021 Class II | Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0795-2021 Class II | Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0794-2021 Class II | Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0793-2021 Class II | Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0792-2021 Class II | Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0791-2021 Class II | Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0790-2021 Class II | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0789-2021 Class II | Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0788-2021 Class II | Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0787-2021 Class II | Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10…Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing… | Steris Corporation | 12/02/2020Terminated |
| Z-0786-2021 Class II | Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10…Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam… | Steris Corporation | 12/02/2020Terminated |
| Z-0771-2018 Class II | Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0770-2018 Class II | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0769-2018 Class II | Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0768-2018 Class II | Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0767-2018 Class II | Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0766-2018 Class II | Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0765-2018 Class II | Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0764-2018 Class II | Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0763-2018 Class II | Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0762-2018 Class II | Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0761-2018 Class II | Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0760-2018 Class II | Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0759-2018 Class II | Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0758-2018 Class II | Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0757-2018 Class II | Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0756-2018 Class II | Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0755-2018 Class II | Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0754-2018 Class II | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0753-2018 Class II | Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0752-2018 Class II | Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0751-2018 Class II | Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0750-2018 Class II | Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0749-2018 Class II | Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0748-2018 Class II | Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0747-2018 Class II | Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per case 6…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0746-2018 Class II | Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0745-2018 Class II | Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0744-2018 Class II | Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-0743-2018 Class II | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | Steris Corporation | 06/15/2017Terminated |
| Z-1312-2015 Class II | Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because… | Advanced Sterilization Products | 12/24/2014Terminated |
| Z-0434-2014 Class III | STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902…Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have… | Advanced Sterilization Products | 10/03/2013Terminated |
| Z-0995-2013 Class II | KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square.…Some individual container filter units might contain thin areas that may potentially compromise the ability… | Kimberly-Clark Corporation | 03/06/2013Terminated |