Needle, Aspiration And Injection, Disposable
FDA product code GAA · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
107510(k) clearances
0PMA approvals
33recalls
Manufacturers
- A.D.T. Lab Industries 14
- Dlp, Inc. 5
- R. J. Doyle, Inc. 4
- Symbiosis Corp. 4
- National Patent Development Corp. 4
- Medical Device Technologies, Inc. 3
- Wilson-Cook Medical, Inc. 3
- Ocean Medical Products, Ltd. 3
- Manan Manufacturing Co., Inc. 3
- Manan Medical Products, Inc. 3
- Ximed/Prosure/Injectx 2
- Sherwood Medical Co. 2
- Creative Research and Mfg., Inc. 2
- Pharmaco, Inc. 2
- National-Standard Medical Products 2
- Jelco Laboratories 2
- Medsurg Industries, Inc. 2
- Southland Instruments, Inc. 2
- Medline Industries, LP 1
- Pneumeric, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223625 | CapnoSpot Pneumothorax Decompression IndicatorGAA · Traditional | Pneumeric, Inc. | 03/28/2023SE |
| K102274 | Arvik Laparoscopic Aspiration InstrumentGAA · Traditional | Arvik Enterprises/ Mini Lap Technologies | 06/15/2011SE |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
| K994151 | Percutx-Injection/Aspiration Needle Probes/DevicesGAA · Traditional | Ximed/Prosure/Injectx | 03/01/2000SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | Ximed/Prosure/Injectx | 12/11/1998SE |
| K974741 | Manan Accura NeedleGAA · Traditional | Medical Device Technologies, Inc. | 01/08/1998SE |
| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
| K961959 | MD Tech Biopsy Set for Bone and Bone MarrowGAA · Traditional | Medical Device Technologies, Inc. | 07/19/1996SE |
| K945109 | Monoject Bone Marrow Biopsy TraysGAA · Traditional | Sherwood Medical Co. | 11/14/1994SE |
| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
| K940024 | Manan General Purpose Introducer NeedleGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
| K930158 | Bone Marrow Biopsy Procedure TrayGAA · Traditional | Symbiosis Corp. | 07/02/1993SEKD |
| K925621 | Irrigation/Aspiration Tubing SetGAA · Traditional | Kirwan Surgical Products, Inc. | 05/07/1993SE |
| K924501 | Gillam-Tukel Bone Marrow Biopsy NeedleGAA · Traditional | Symbiosis Corp. | 04/20/1993SE |
| K925416 | Symbiosis Bone Marrow Biopsy NeedleGAA · Traditional | Symbiosis Corp. | 02/23/1993SE |
| K922614 | Turkel Thoracentesis SystemGAA · Traditional | Symbiosis Corp. | 07/30/1992SE |
| K915417 | Kopan's TargetGAA · Traditional | Medical Device Technologies, Inc. | 01/14/1992SE |
| K914608 | Breast Les Local Wire St. 48219/49220/48119/48120GAA · Traditional | Dlp, Inc. | 01/09/1992SE |
| K913992 | Aspiration/Injection NeedleGAA · Traditional | Northgate Technologies, Inc. | 10/30/1991SE |
| K912074 | Bone Marrow Biopsy TrayGAA · Traditional | Manan Medical Products, Inc. | 08/28/1991SE |
| K910036 | Surg Tech,Inc. 30 Gauge Straight Extrusion NeedlesGAA · Traditional | Surgical Technologies, Inc. | 04/04/1991SE |
| K910117 | Reddick Irrigation/Aspiration SystemGAA · Traditional | Ideal Medical, Inc. | 03/19/1991SE |
| K901438 | Sure-Stop Transbronchial Aspiration NeedleGAA · Traditional | Telemed Systems, Inc. | 05/24/1990SE |
| K897050 | Wilson-Cook Lung Biopsy NeedleGAA · Traditional | Wilson-Cook Medical, Inc. | 04/16/1990SE |
| K896606 | Jackson Fine Needle Aspiration SystemGAA · Traditional | National-Standard Medical Products | 01/04/1990SE |
| K896605 | Kopans Stabilized Needle Aspiration Guide (Snag)GAA · Traditional | National-Standard Medical Products | 01/04/1990SE |
| K896019 | Modified Disp. Chiba-Type Needle Designated Aspi.GAA · Traditional | Dlp, Inc. | 01/03/1990SE |
| K895012 | E-Z-Em Vacuum Aspiration SyringeGAA · Traditional | E-Z-Em, Inc. | 12/27/1989SE |
| K894875 | 20GA X 7-1/2 Threading Bullet Point NeedleGAA · Traditional | R. J. Doyle, Inc. | 09/22/1989SE |
| K894874 | 14 Inch Bullet Point NeedleGAA · Traditional | R. J. Doyle, Inc. | 09/22/1989SE |
| K894873 | 16 Ga X 10 Bullet Point NeedleGAA · Traditional | R. J. Doyle, Inc. | 09/22/1989SE |
| K894872 | 16 Ga X 6 Bullet Point NeedleGAA · Traditional | R. J. Doyle, Inc. | 09/22/1989SE |
| K894326 | Thoracentisis KitGAA · Traditional | Mill-Rose Laboratory | 07/24/1989SE |
| K883014 | Modified Intended Use of Monoject Bone Marrow NeedGAA · Traditional | Sherwood Medical Co. | 07/28/1988SE |
| K882105 | Code #D2020-FINE Needle Aspiration Biopsy SystemGAA · Traditional | Dianon Systems, Inc. | 07/11/1988SESD |
| K880377 | Novo Vivo Model #17140 and #17135GAA · Traditional | Genesis Industries, Inc. | 04/04/1988SE |
| K874000 | Pria-Kit (TM) Priapism Kit S.S.GAA · Traditional | Canton Medical, Inc. | 12/30/1987SESD |
| K873124 | Anchor Biopsy NeedleGAA · Traditional | Anchor Products Co. | 09/08/1987SE |
| K870893 | Medsurg Chiba PTC NeedleGAA · Traditional | Medsurg Industries, Inc. | 03/25/1987SE |
| K870896 | Notch-Needle, Wescott StyleGAA · Traditional | Ocean Medical Products, Ltd. | 03/18/1987SE |
| K864800 | Namic Chiba Aspiration Biopsy NeedleGAA · Traditional | North American Instrument Corp. | 02/06/1987SE |
| K864139 | Ranfac Cut Biopsy NeedleGAA · Traditional | Ranfac, Corp. | 11/05/1986SE |
| K863848 | Manan Brest Tumor Localization NeedleGAA · Traditional | Manan Manufacturing Co., Inc. | 10/14/1986SE |
| K863326 | Bone Marrow TrayGAA · Traditional | Packaging Technologies, Inc. | 09/16/1986SE |
| K860582 | Tbi NeedleGAA · Traditional | Hobbs Medical, Inc. | 03/04/1986SE |
| K855141 | Angiomed Fine Needles and Needle SetGAA · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854579 | Hypodermic Needle and StyletGAA · Traditional | Berkley and Co. | 12/17/1985SE |
| K854238 | Needle W/Stylet for ImplantationGAA · Traditional | Microvasive | 11/13/1985SE |
| K853980 | Erosa Disposable Hypodermic NeedleGAA · Traditional | Rose KG | 10/18/1985SE |
| K852897 | Lee Bone Marrow Biopsy/Aspiration TrayGAA · Traditional | Southland Instruments, Inc. | 08/21/1985SESD |
| K852817 | Sterile, Disposable NeedleGAA · Traditional | Fabersanitas, S.A. | 07/26/1985SE |
| K852427 | Manan Spinal NeedleGAA · Traditional | Manan Manufacturing Co., Inc. | 06/27/1985SE |
| K852426 | Manan Trocar Style Biopsy NeedleGAA · Traditional | Manan Manufacturing Co., Inc. | 06/27/1985SE |
| K851957 | Chiba NeedleGAA · Traditional | Wilson-Cook Medical, Inc. | 05/17/1985SE |
| K851953 | Hawkin NeedleGAA · Traditional | Wilson-Cook Medical, Inc. | 05/17/1985SE |
| K843925 | Gill's Irrigator/Aspirator NeedleGAA · Traditional | Concept, Inc. | 11/05/1984SE |
| K843083 | Cormed Huber Point NeedleGAA · Traditional | Cormed, Inc., Sub. C.R.Bard, Inc. | 09/05/1984SE |
| K842230 | Aimed Dispos. Injection NeedleGAA · Traditional | Tech-Cons Ltd., Intl. | 08/17/1984SE |
| K842106 | Lee Bone Marrow NeedlesGAA · Traditional | Southland Instruments, Inc. | 08/10/1984SE |
| K842699 | Islam Bone Marrow Aspiration NeedlesGAA · Traditional | Downs Surgical , Ltd. | 08/02/1984SE |
| K841301 | Gardner Type Bone Marrow NeedleGAA · Traditional | Popper & Sons, Inc. | 06/05/1984SE |
| K840922 | Intradiscal Therapy Needle 18 GaugeGAA · Traditional | Dlp, Inc. | 04/24/1984SE |
| K832626 | Top Sterile Dispos. Hypodermic NeedlesGAA · Traditional | Top Surgical Manufacturers Co. | 10/14/1983SE |
| K831392 | Tru-Cut Biopsy/Aspira-Needle 2N2709GAA · Traditional | Travenol Laboratories, S.A. | 07/12/1983SE |
| K830378 | Sterile, Disposable, Hypodermic NeedlesGAA · Traditional | Abco Dealers, Inc. | 03/24/1983SE |
| K821697 | Injection Aspirating NeedlesGAA · Traditional | American Endoscopy, Inc. | 06/25/1982SE |
| K821017 | Various Sterile Biopsy Aspiration NeedGAA · Traditional | Medsurg Industries, Inc. | 06/22/1982SE |
| K821348 | Hypodermic Needles & SyringesGAA · Traditional | Medi-Tech, Inc. | 06/10/1982SE |
| K820502 | Siloam Save-A-NeedleGAA · Traditional | Siloam, Inc. | 03/15/1982SE |
| K820070 | Msi Sternum Aspiration NeedleGAA · Traditional | Creative Research and Mfg., Inc. | 02/04/1982SE |
| K813460 | Chiba Skinny NeedleGAA · Traditional | Ocean Medical Products, Ltd. | 01/07/1982SE |
| K813448 | Potts-Cournand Style NeedleGAA · Traditional | Ocean Medical Products, Ltd. | 01/07/1982SE |
| K813368 | Disposable Chiba-Type NeedleGAA · Traditional | Dlp, Inc. | 01/05/1982SE |
| K813367 | Cuatico Myelography NeedlesGAA · Traditional | Dlp, Inc. | 01/05/1982SE |
| K811771 | A.D.T. Reusable Bone Marrow NeedleGAA · Traditional | Lab Industries, Inc. | 07/10/1981SE |
| K810248 | Msi Bone Marrow Biopsy Needle W/J TipGAA · Traditional | Creative Research and Mfg., Inc. | 03/20/1981SE |
| K810076 | Pheresis Needle AssemblyGAA · Traditional | Haemonetics Corp. | 03/05/1981SE |
| K801754 | Adt Bone Marrow Aspiration NeedleGAA · Traditional | A.D.T. Lab Industries | 08/20/1980SE |
| K801753 | Adt Bone Marrow Biopsy-Aspir. NeeldeGAA · Traditional | A.D.T. Lab Industries | 08/20/1980SE |
| K801457 | Accu-Core Disposable Biopsy NeedleGAA · Traditional | Medline Industries, Inc. | 07/14/1980SE |
| K800417 | Adt PTC Pro. Tray W/(Skinny Chiba) NeedlGAA · Traditional | A.D.T. Lab Industries | 04/28/1980SE |
| K800414 | Adt Soft Tissue Biopsy TrayGAA · Traditional | A.D.T. Lab Industries | 04/28/1980SE |
| K800412 | Rosenthal Needle (Disp.) Adt Bone MarrowGAA · Traditional | A.D.T. Lab Industries | 04/28/1980SE |
| K800411 | Aspiration Tray W/Ferris Disp. IllinoisGAA · Traditional | A.D.T. Lab Industries | 04/28/1980SE |
| K800410 | Adt Bone Marrow Biopsy-Aspiration TrayGAA · Traditional | A.D.T. Lab Industries | 04/28/1980SE |
| K800409 | Adt Bone Marrow Biopsy Aspiration TrayGAA · Traditional | A.D.T. Lab Industries | 04/28/1980SE |
| K800408 | Adt Bone Mar. Bio/Asp. Tray W/NeedleGAA · Traditional | A.D.T. Lab Industries | 04/28/1980SE |
| K800423 | Adt Nerve Block Tray(Disp.)GAA · Traditional | A.D.T. Lab Industries | 03/25/1980SE |
| K800421 | Adt Peritoneal Lavage Tray (Disp.)GAA · Traditional | A.D.T. Lab Industries | 03/25/1980SE |
| K800415 | Adt Menghini Type Soft Tissue BiopsyGAA · Traditional | A.D.T. Lab Industries | 03/25/1980SE |
| K800413 | Ferris Modified Disp. Il Sternal-IliacGAA · Traditional | A.D.T. Lab Industries | 03/25/1980SE |
| K800407 | Ferris Bone Marrow -Needle-(Disposable)GAA · Traditional | A.D.T. Lab Industries | 03/12/1980SE |
| K800153 | Extemp/Extemp-VGAA · Traditional | Pharma-Filter, Inc. | 02/06/1980SE |
| K790472 | Burron Vented NeedleGAA · Traditional | National Patent Development Corp. | 03/26/1979SE |
| K790060 | Needle II, Burron FilterGAA · Traditional | National Patent Development Corp. | 03/21/1979SE |
| K790142 | Needle, with FilterGAA · Traditional | National Patent Development Corp. | 02/26/1979SE |
| K790061 | Needle, Burron FilterGAA · Traditional | National Patent Development Corp. | 02/16/1979SE |
| K790079 | Needle, Blood CollectingGAA · Traditional | Jelco Laboratories | 02/01/1979SE |
| K781371 | Bone Marrow Aspiration KitGAA · Traditional | Ferris Mfg. Corp. | 09/20/1978SE |
| K781264 | Pab Convenience TrayGAA · Traditional | Waters Assoc., Inc. | 09/20/1978SE |
| K780887 | Improved Disposable Hypodermic NeedleGAA · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 06/22/1978SE |
| K780624 | Culdocentesis TrayGAA · Traditional | Cutter Laboratories, Inc. | 05/26/1978SE |
| K771784 | Iopsy Tray for Soft Tissue BiopsyGAA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/30/1977SE |
| K771760 | ExtempGAA · Traditional | Pharmaco, Inc. | 09/28/1977SE |
| K771759 | Extemp-VGAA · Traditional | Pharmaco, Inc. | 09/28/1977SE |
| K760775 | Terumo Disposable Spinal NeedleGAA · Traditional | Terumo America, Inc. | 11/01/1976SE |
| K760022 | Needle, FilterGAA · Traditional | Jelco Laboratories | 08/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0018-2023 Class II | Hobbs Transbronchial Aspiration Needle Catalog Number: 4621Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0017-2023 Class II | Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number:…Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-2520-2021 Class II | 10 ga ARS Decompression Needle, Part Number ZZ-0298The device includes the incorrect Instructions for Use. | North American Rescue LLC. | 08/27/2021Terminated |
| Z-2490-2021 Class II | Aspirated Cyto-Histological Biopsy needleSterility assurance may be compromised. | M.D.L. S.r.l. | 08/05/2021Terminated |
| Z-2164-2021 Class II | Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following…Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized | Innovative Tomography Product GmbH | 04/21/2021Open, Classified |
| Z-2163-2021 Class II | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following…Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized | Innovative Tomography Product GmbH | 04/21/2021Open, Classified |
| Z-2162-2021 Class II | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following…Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized | Innovative Tomography Product GmbH | 04/21/2021Open, Classified |
| Z-1058-2021 Class II | NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1057-2021 Class II | NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1056-2021 Class II | NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1055-2021 Class II | NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1054-2021 Class II | NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-2612-2023 Class II | TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air…Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2)… | Tytek Medical Inc | 10/05/2020Terminated |
| Z-2611-2023 Class II | TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for…Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2)… | Tytek Medical Inc | 10/05/2020Terminated |
| Z-2610-2023 Class II | TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction…Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2)… | Tytek Medical Inc | 10/05/2020Terminated |
| Z-0861-2020 Class II | VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0860-2020 Class II | VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0859-2020 Class II | VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0858-2020 Class II | VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0857-2020 Class II | VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0850-2020 Class II | VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0849-2020 Class II | VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0848-2020 Class II | (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF…Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0847-2020 Class II | (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush…Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0846-2020 Class II | (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush…Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-2365-2015 Class II | Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel. | Cadence Inc. | 07/09/2015Terminated |
| Z-2364-2015 Class II | Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel. | Cadence Inc. | 07/09/2015Terminated |
| Z-2107-2013 Class II | SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration…SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval. | SpineNet | 02/04/2013Terminated |
| Z-1063-2011 | Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2…This lot of product has the wrong expiration date on the carton label. The pouches contained the correct… | Inrad, Inc | 12/20/2010Terminated |
| Z-0023-2011 | BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use…There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles | Becton Dickinson & Company | 08/24/2010Terminated |
| Z-2017-2010 | Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | Medical Device Technologies, Inc. | 09/01/2009Terminated |
| Z-1912-2009 | Broselow/Hinkle Pediatric Emergency System; Contents: 1 15 Ga Adjustable Length…Not compatible: The luer connector on the Intraosseus needle provided does not fit securely on the luer… | Vital Signs Inc | 06/30/2009Terminated |
| Z-1878-2008 | Hawkins III Breast Localization Needle. Product number 243075. The product is used in…The sterility of the product cannot be guaranteed. | Medical Device Technologies, Inc. | 05/06/2008Terminated |
| Z-0855-2008 | Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and…Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits… | First Aid Only Inc | 12/10/2007Terminated |