Catheter, Retention Type, Balloon
FDA product code EZL · Class II (moderate risk) · 21 CFR 876.5130 · Gastroenterology, Urology
130510(k) clearances
0PMA approvals
85recalls
Manufacturers
- C.R. Bard, Inc. 10
- Regulatory & Marketing Services, Inc. 6
- Amsino International, Inc. 5
- Rusch Intl. 4
- Opticon Medical, Inc. 4
- Teleflexmedical, Inc. 4
- Silq Technologies Corporation 3
- Degania Silicone, Ltd. 3
- Rochester Medical Corp 3
- Well Lead Medical Co., Ltd. 3
- Cook Urological, Inc. 3
- Medline Industries, LP 3
- Mri Manufacturing and Research, Inc. 2
- Fortune Medical Instrument Corp. 2
- Louisville Laboratories, Inc. 2
- Porges S.A. 2
- Tyco Healthcare 2
- Seedings Life Science Ventures, LLC 2
- Teleflex Medical Sdn. Bhd. 2
- Rusch, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional | Sentinel Medical Technologies, | 09/04/2026SE |
| K262056 | Rusch Latex Gold Foley CatheterEZL · Traditional | Teleflex Medical Sdn. Bhd. | 08/05/2026SE |
| K252537 | Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflex Medical Sdn. Bhd. | 01/20/2026SE |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional | Guangdong Ecan Medical Co., Ltd. | 06/16/2025SE |
| K241424 | InnoCare Specialty Foley CatheterEZL · Traditional | Innocare Urologics, LLC | 09/18/2024SE |
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | Teleflexmedical, Inc. | 08/01/2024SE |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional | Sentinel Medical Technologies, LLC | 04/17/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | Coloplast Corp. | 04/15/2024SE |
| K233013 | 2-Way 100% Silicone Cleartract CatheterEZL · Traditional | Silq Technologies Corporation | 01/23/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflexmedical, Inc. | 07/27/2023SE |
| K231101 | Flume CatheterEZL · Special | Flume Catheter Company, Ltd. | 06/29/2023SE |
| K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn…EZL · Traditional | Potrero Medical, Inc. | 01/13/2023SESK |
| K222118 | 2-Way 100% Silicone Cleartract CatheterEZL · Traditional | Silq Technologies, Corp. | 12/01/2022SE |
| K221625 | 2-Way 100% Silicone ClearTract CatheterEZL · Special | Silq Technologies Corporation | 07/01/2022SE |
| K212151 | FLUME catheterEZL · Traditional | The Flume Catheter Company, Ltd. | 11/03/2021SE |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature SensorEZL · Special | Well Lead Medical Co., Ltd. | 04/08/2021SE |
| K201776 | Foley Balloon Catheter for UrologyEZL · Traditional | Apollon Co., Ltd. | 12/30/2020SE |
| K202698 | Prefilled SyringeEZL · Traditional | Hangzhou Primecare Medical Co., Ltd. | 12/15/2020SE |
| K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley…EZL · Traditional | Pathway, LLC | 04/21/2020SE |
| K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mLEZL · Traditional | H R Pharmaceuticals, Inc. | 03/31/2020SE |
| K182463 | Silicone Foley CatheterEZL · Traditional | Biosensors International Pte, Ltd. | 11/06/2019SE |
| K190060 | Urethrotech UCDEZL · Traditional | Urethrotech | 10/04/2019SE |
| K182635 | Signal CatheterEZL · Traditional | Safe Medical Design | 01/10/2019SE |
| K181616 | PSM 3-Way Silicone Foley CatheterEZL · Traditional | Pathway, LLC | 09/21/2018SE |
| K180781 | Bard Vertus Foley CatheterEZL · Traditional | C.R. Bard, Inc. | 09/19/2018SE |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterEZL · Traditional | Amsino International, Inc. | 09/04/2018SE |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley CatheterEZL · Traditional | Cook Incorporated | 08/23/2018SE |
| K181346 | CystoSure Plus CatheterEZL · Traditional | Emmy Medical, LLC | 08/06/2018SE |
| K173340 | Yikang Latex Foley CatheterEZL · Traditional | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 07/13/2018SE |
| K172807 | Silicone Foley Catheter for single useEZL · Traditional | Changzhou Rongxin Medicine Minimal Invasion… | 06/04/2018SE |
| K173533 | Duette 100% Silicone Dual-Balloon, Temperature-Sensing CatheterEZL · Traditional | Poiesis Medical, LLC | 03/29/2018SE |
| K172422 | Kohli Urinary Drainage CatheterEZL · Traditional | Nellie Medical, LLC | 02/09/2018SE |
| K161770 | Rusch Silicone Foley CatheterEZL · Traditional | Teleflexmedical, Inc. | 05/05/2017SE |
| K162989 | Rusch Simplastic Foley CathetersEZL · Traditional | Teleflexmedical, Inc. | 02/24/2017SE |
| K153655 | Accuryn Monitoring SystemEZL · Traditional | Potrero Medical, Inc. | 04/15/2016SESK |
| K150550 | SilverCoat Silicone Foley CatheterEZL · Traditional | Covalontechnologies, Inc. | 11/24/2015SE |
| K150699 | Bard LubriGuard Foley CatheterEZL · Traditional | C.R. Bard, Inc. | 07/28/2015SE |
| K142635 | Medline Silicone Foley CatheterEZL · Traditional | Medline Industries, Inc. | 01/09/2015SE |
| K140667 | Well Lead Hydrophilic Silicone Foley CatheterEZL · Traditional | Well Lead Medical Co., Ltd. | 12/15/2014SE |
| K140099 | Lighthouse Urinary CatheterEZL · Traditional | Seedings Life Science Ventures, LLC | 03/04/2014SE |
| K131655 | Lighthouse(Tm) Urinary CatheterEZL · Traditional | Seedings Life Science Ventures, LLC | 11/04/2013SE |
| K130908 | Disposable Silicone Foley CatheterEZL · Traditional | Guangdong Baihe Medical Technology Co., Ltd. | 10/03/2013SE |
| K131020 | Temperature Sensor CatheterEZL · Special | Degania Silicone , Ltd. | 05/09/2013SE |
| K110214 | Directvision Catheter, UncoatedEZL · Special | Percuvision | 05/27/2011SE |
| K103371 | Coude/ or TiemannEZL · Traditional | Degania Silicone , Ltd. | 03/11/2011SE |
| K101824 | Amsure 3-WAY Hydrophilic Latex Foley CatheterEZL · Traditional | Amsino International, Inc. | 09/13/2010SE |
| K091516 | Well Lead Silicone Catheter with Temperature SensorEZL · Traditional | Well Lead Medical Co., Ltd. | 10/16/2009SE |
| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | Cook Urological, Inc. | 10/09/2009SE |
| K091699 | Amsure Hydrophilic Latex Foley CatheterEZL · Special | Amsino International, Inc. | 08/10/2009SE |
| K090262 | Percucath Urinary CatheterEZL · Traditional | Percuvision, LLC | 05/28/2009SE |
| K082919 | Uc-Care Positioning SystemEZL · Traditional | Uc-Care Medical Systems, Ltd. | 10/27/2008SE |
| K082815 | Well Lead Silicone and Latex Foley CathetersEZL · Traditional | Well Lead Medical Instruments | 10/08/2008SE |
| K070582 | Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing…EZL · Traditional | C.R. Bard, Inc. | 12/07/2007SE |
| K070558 | Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone Foley CathetersEZL · Traditional | C.R. Bard, Inc. | 12/07/2007SE |
| K071049 | Dover 100% Silicone Foley Catheter with Temperature SensorEZL · Traditional | Tyco Healthcare | 10/16/2007SE |
| K071423 | Medline Latex Foley CatheterEZL · Abbreviated | Medline Industries, Inc. | 07/18/2007SE |
| K062112 | Sunmed Foley CathetersEZL · Traditional | Sunmed, Inc. | 06/04/2007SE |
| K063442 | All Silicone Foley Catheter, 2-WAY, 3-WAY, with Temperature SensorEZL · Traditional | Degania Silicone , Ltd. | 03/26/2007SE |
| K070508 | Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FREZL · Traditional | C.R. Bard, Inc. | 03/09/2007SE |
| K052168 | Medline Silvertouch 100% Silicone Foley Catheter, Model Medline Industries, Inc.EZL · Traditional | Medline Industries, Inc. | 02/16/2006SE |
| K053429 | Advanced Urological CatheterEZL · Traditional | Entracare, LLC | 02/08/2006SE |
| K051059 | Amsure 100% Silicone Foley CatheterEZL · Traditional | Amsino International, Inc. | 06/28/2005SE |
| K042110 | BeamcathEZL · Traditional | Beampoint AB | 02/25/2005SE |
| K042709 | Dover Silver Temperature Sensing Foley CatheterEZL · Traditional | Tyco Healthcare | 01/18/2005SE |
| K041983 | Option-Vm Urinary Catheter/Adpater, Models MV39016, MVA39016EZL · Traditional | Opticon Medical | 11/17/2004SE |
| K040504 | Bardex, Lubri-Sil and Lubri-Sil Ic All-Silicone Foley CathetersEZL · Traditional | C.R. Bard, Inc. | 05/14/2004SE |
| K033830 | Option-Vf Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage…EZL · Special | Opticon Medical, Inc. | 01/09/2004SE |
| K030120 | Amsure Foley CatheterEZL · Traditional | Amsino International, Inc. | 10/29/2003SE |
| K031748 | Vitalcare Sterilewater and 0.9% Sodium Chloride Pre-Filled 10CC/30CC SyringesEZL · Traditional | Vitalcare Group, Inc. | 08/27/2003SE |
| K024010 | Dover Silver Hydrogel Coated Silicone Foley CatheterEZL · Traditional | The Kendall Company Div. of Tyco Healthcare Group | 06/11/2003SE |
| K030813 | Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile…EZL · Traditional | Primary Care Solutions, Inc. | 05/30/2003SE |
| K021939 | Vitalcare Foley CatheterEZL · Traditional | Vitalcare, Inc. | 04/22/2003SE |
| K023090 | Option-Vf Urinary Catheter, FV14218EZL · Traditional | Opticon Medical, Inc. | 03/19/2003SE |
| K021142 | All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865EZL · Traditional | Fortune Medical Instrument Corp. | 10/01/2002SE |
| K022287 | 3T/SEWOON Temperature Sensing Foley CathetersEZL · Traditional | 3t Medical Systems, LLC | 09/23/2002SE |
| K002612 | Bardex I.C.Plus Foley Catheter with Silver Salts in Hydrogel Coating, Model 3CC Balloon:…EZL · Abbreviated | C.R. Bard, Inc. | 09/03/2002SE |
| K013276 | All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)EZL · Traditional | Sewoon Medical Co., Ltd. | 02/15/2002SE |
| K013174 | Proges Folysil Silicone Foley Catheter, Straight Cylindrical Tip, Silicone Female Foley…EZL · Abbreviated | Porges S.A. | 01/04/2002SE |
| K013172 | Porges Silicone Prostatectomy Catheter, Straight Cylindrical Tip, Delinotte Tip, Dufour…EZL · Abbreviated | Porges S.A. | 12/20/2001SE |
| K010006 | Drainage Catheter or Foley CatheterEZL · Traditional | Applied Medical Resources Corp. | 07/25/2001SE |
| K003784 | Mentor Self-Cath PlusEZL · Traditional | Mentor Corp. | 03/05/2001SE |
| K003289 | Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex Lubri-Sil…EZL · Abbreviated | C.R. Bard, Inc. | 01/05/2001SE |
| K002868 | Bard All-Silicone 3-WAY Foley Catheter; Bard Lubri-Sil 3-WAY Foley Catheter; Bard…EZL · Abbreviated | C.R. Bard, Inc. | 12/08/2000SE |
| K993063 | Rusch Brillant Silicone FoleyEZL · Traditional | Rusch Intl. | 12/09/1999SE |
| K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…EZL · Abbreviated | The Kendal Co. | 09/28/1999SE |
| K990509 | Oligon Foley Catheter (16 FR) #33816/OLIGON Foley Catheter (18 FR) #33818EZL · Abbreviated | Implemed, Inc. | 05/18/1999SE |
| K984084 | Bardex Lubri-Sil Foley CatheterEZL · Traditional | Bard Medical Div. | 02/01/1999SE |
| K982970 | Mri's All Silicone Irrigation 3-WAY Foley CatheterEZL · Traditional | Mri Manufacturing and Research, Inc. | 10/28/1998SE |
| K973076 | Euromedical Haematuria Foley CatheterEZL · Traditional | Unomedical Sdn Bhd | 09/16/1998SE |
| K982626 | Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit…EZL · Special | Medworks Corp. | 08/20/1998SE |
| K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…EZL · Traditional | Rochester Medical Corp. | 07/08/1998SE |
| K980870 | Rusch Silicone Foley CatheterEZL · Traditional | Rusch, Inc. | 06/09/1998SE |
| K980919 | All Silicone 2-WAY & 3-WAY Foly Balloon Catheter and Nelaton CatheterEZL · Traditional | Fortune Medical Instrument Corp. | 03/31/1998SE |
| K974419 | Rusch Simplastic Councill Tip CatheterEZL · Traditional | Rusch, Inc. | 01/27/1998SE |
| K972184 | Rusch Brillant Silicone Foley CatheterEZL · Traditional | Rusch Intl. | 01/08/1998SE |
| K971643 | Rusch Brillant Balloon CatheterEZL · Traditional | Rusch Intl. | 10/07/1997SE |
| K971796 | Laparotomy Bladder Neck Suspension Kit with Bone AnchorsEZL · Traditional | Louisville Laboratories, Inc. | 08/12/1997SE |
| K971801 | Laparotomy Bladder Neck Suspension KitEZL · Traditional | Louisville Laboratories, Inc. | 07/22/1997SE |
| K964757 | Contidrain CatheterEZL · Traditional | Contimed, Inc. | 06/25/1997SE |
| K970716 | Opticon Direct Male Urinary Catheter for Continuous DrainageEZL · Traditional | Opticon Medical, Inc. | 05/16/1997SE |
| K964575 | Sympacath Hydrogel Coated FoleyEZL · Traditional | Rusch Intl. | 02/04/1997SE |
| K961697 | Opticon Female Urinary Incontinence Catheter for Continuous DrainageEZL · Traditional | Medical Device Intl., Inc. | 08/30/1996SE |
| K944673 | Mri's All Silicone Foley Catheter Temperature ProbeEZL · Traditional | Regulatory & Marketing Services, Inc. | 04/10/1996SE |
| K944676 | Mri's All Silicone Foley CatheterEZL · Traditional | Mri Manufacturing and Research, Inc. | 04/05/1996SE |
| K954752 | Pediatric Europhylic Foley CatheterEZL · Traditional | Regulatory & Marketing Services, Inc. | 10/30/1995SE |
| K944007 | Europhilic Slippery Coated Foley CatheterEZL · Traditional | Baxter Healthcare Corp | 06/29/1995SE |
| K951106 | Silicone Foley CatheterEZL · Traditional | Cook Urological, Inc. | 05/25/1995SE |
| K951103 | Silastic Brand Foley CatheterEZL · Traditional | C.R. Bard, Inc. | 04/28/1995SE |
| K945806 | Silicath All Silicone Foley CatheterEZL · Traditional | Unomedical Sdn Bhd | 03/21/1995SE |
| K941692 | Female Length All Silicone Urological CatheterEZL · Traditional | Rochester Medical Corp. | 03/06/1995SE |
| K944382 | Orion All Silicone Foley CatheterEZL · Traditional | Regulatory & Marketing Services, Inc. | 12/06/1994SE |
| K944381 | Orion All Silicone Foley Catheter Temperature ProbeEZL · Traditional | Regulatory & Marketing Services, Inc. | 11/30/1994SE |
| K944380 | Orion Foley CatheterEZL · Traditional | Regulatory & Marketing Services, Inc. | 11/30/1994SE |
| K944376 | Orion All Silicone Elastomer Coated CatheterEZL · Traditional | Regulatory & Marketing Services, Inc. | 11/30/1994SE |
| K941488 | Devmed Double-Balloon Urological CatheterEZL · Traditional | Medical Technology Development Corp. | 11/30/1994SE |
| K934895 | Glassman Silicone CatheterEZL · Traditional | Axiom Medical, Inc. | 10/13/1994SE |
| K935630 | NortaEZL · Traditional | Beiersdorf, Inc. | 10/07/1994SE |
| K930344 | Silicone Foley CatheterEZL · Traditional | Cook Urological, Inc. | 04/15/1994SE |
| K932809 | Frangi-Cath Safe-Release(Tm) ConnectorEZL · Traditional | Excalibur Engineering Care of Rms, Inc. | 03/17/1994SE |
| K911617 | Urotech CatheterEZL · Traditional | Urotech U.S.A., Inc. | 02/25/1993SE |
| K922821 | Ysi Models 4700 Foley Catheter Temperature ProbesEZL · Traditional | Yellow Springs Instrument Co., Inc. | 11/23/1992SE |
| K921561 | Ysi Models 4400 Foley Catheter Temperature ProbesEZL · Traditional | Ysis, Inc. | 11/23/1992SE |
| K905042 | Comfort Sleeved All Silicone Foley CatheterEZL · Traditional | Rochester Medical Corp. | 01/18/1991SE |
| K903777 | WRP FoleycathEZL · Traditional | Wembley Rubber Products (M) Sdn Bhd | 12/13/1990SE |
| K902710 | Foley CatheterEZL · Traditional | Societa Gruppi Elastomeri S.A. | 11/21/1990SE |
| K894883 | Phycon All Silicone Balloon CatheterEZL · Traditional | Vitaid, Ltd. | 04/25/1990SE |
| K810691 | Curity 100% Silicone Irrigation FoleyEZL · Traditional | The Kendal Co. | 03/13/1981SESP |
| K780062 | Catheter/Hemostatic/GeriatricEZL · Traditional | Kendall Research Center | 02/14/1978SE |
| K772218 | Catheter, Silicone CoatedEZL · Traditional | Concord Laboratories, Inc. | 12/13/1977SE |
| K771860 | Folhy CatheterEZL · Traditional | Polysil, Inc. | 10/18/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3115-2026 Class II | Products that contain the Pericare Wipes: Bard Foley Tray With Lubri-Sil All-Silicone…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | C.R. Bard Inc | 06/25/2026Open, Classified |
| Z-2226-2026 Class II | Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422…Due to stain present on the surface of affected foley catheters. | C.R. Bard Inc | 04/23/2026Open, Classified |
| Z-2462-2025 Class II | Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone…Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine… | C.R. Bard Inc | 06/18/2025Open, Classified |
| Z-0845-2025 Class II | X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120…A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | Coloplast Manufacturing US, LLC | 12/02/2024Open, Classified |
| Z-0844-2025 Class II | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110…A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | Coloplast Manufacturing US, LLC | 12/02/2024Open, Classified |
| Z-1050-2024 Class I | Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | Cardinal Health 200, LLC | 12/04/2023Open, Classified |
| Z-0515-2024 Class I | Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE…Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have… | Nurse Assist, LLC | 11/06/2023Open, Classified |
| Z-2541-2021 Class II | Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock"…There is potential for packaging defects that may impact the sterile barrier. | C.R. Bard Inc | 08/05/2021Open, Classified |
| Z-2540-2021 Class II | Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete…There is potential for packaging defects that may impact the sterile barrier. | C.R. Bard Inc | 08/05/2021Open, Classified |
| Z-2539-2021 Class II | Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization…There is potential for packaging defects that may impact the sterile barrier. | C.R. Bard Inc | 08/05/2021Open, Classified |
| Z-2537-2021 Class II | Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization…There is potential for packaging defects that may impact the sterile barrier. | C.R. Bard Inc | 08/05/2021Open, Classified |
| Z-1789-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1788-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1787-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1786-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1785-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1784-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1783-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1782-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1781-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1780-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-1779-2020 Class II | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product…Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the… | Degania Medical Devices Pvt. Ltd. | 03/17/2020Terminated |
| Z-0809-2020 Class II | Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number:…Temperature deviation did not meet release specifications | Degania Silicone, Ltd. | 12/02/2019Terminated |
| Z-2044-2020 Class II | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline…Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Medline Industries Inc | 05/28/2019Terminated |
| Z-2043-2020 Class II | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline…Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Medline Industries Inc | 05/28/2019Terminated |
| Z-2042-2020 Class II | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline…Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Medline Industries Inc | 05/28/2019Terminated |
| Z-2785-2018 Class II | Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2784-2018 Class II | Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2783-2018 Class II | Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2782-2018 Class II | Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2781-2018 Class II | Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2780-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2779-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2778-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2777-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2776-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2775-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2774-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2773-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2772-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2771-2018 Class II | Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2770-2018 Class II | Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2769-2018 Class II | Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2768-2018 Class II | Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2767-2018 Class II | Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2766-2018 Class II | Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2765-2018 Class II | Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2764-2018 Class II | Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2763-2018 Class II | Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |
| Z-2762-2018 Class II | Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | Degania Silicone, Ltd. | 06/21/2018Terminated |