Collector, Urine, (and Accessories) For Indwelling Catheter
Gastroenterology, Urology · 21 CFR 876.5250
Recent MDR events
2,118 adverse event reports on file
- Tray 16fr Urine Meter Temp R-053657Jul 29, 2026MalfunctionC.r. Bard, Inc50068740
- MedlineJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07970
- Bard® Urinary Drainage Bag with Anti-Reflux ChamberJul 27, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04946
- Bard® Urine Meter with BagJul 27, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04962
- MEDLINEJul 21, 2026MalfunctionMedline Industries, Lp1417592-2026-07261
- MEDLINEJul 21, 2026MalfunctionMedline Industries, Lp1417592-2026-07260
- Unknown Urine CollectionJul 20, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04803
- BARD® URINARY DRAINAGE BAGJul 19, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04782
- BARD® URINE METER WITH BAGJul 17, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04744
- Bard® Flip-Flo¿ Catheter ValveJul 16, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04703
Event type breakdown
Recalls
19 recall events for this product code
- Cardinal Health 200, LLCOpen, ClassifiedFeb 16, 2024
Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONEN
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1046-2024 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
UROLOGY CUSTOMED PACK 5/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2585-2015 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2591-2015 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
UROLOGY PACK 4/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2592-2015 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
UROLOGY PK 5/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2607-2015 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
UROLOGY PK 5/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2608-2015 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
UROLOGY PACK 5/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2708-2015 · View FDA record ↗ - C.R. Bard, Inc.TerminatedApr 1, 2015
Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
Potential breach of the sterile barrier packaging.
Z-1358-2015 · View FDA record ↗ - Teleflex MedicalTerminatedApr 22, 2013
Belly Bag Urine Collection Bag with Hip Belt.
Sterile packaging may be compromised.
Z-1158-2013 · View FDA record ↗ - Covidien LPTerminatedMay 27, 2011
URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe
A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination
Z-2392-2011 · View FDA record ↗
Registered firms
148 firms currently registered for this product code
Allwin Medical Devices Pvt. Ltd.
Surat Gujarat, IN
Fesun Shanghai Co., Ltd.
shanghai, CN
Mendtronix, Inc.
San Diego, CA, US
Medegen Medical Products
GALLAWAY, TN, US
Tuper Medical Co., Ltd.
Dezhou City Shandong, CN
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Eo Canada, Inc.
Mississauga Ontario, CA
Customed, Inc.
Fajardo, PR, US
Amsino Medical (kunshan) Co., Ltd.
KUNSHAN CITY Jiangsu, CN
Guangdong Ecan Medical Co,ltd
Guangzhou Guangdong, CN
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Cardinal Health 200, Llc
Waukegan, IL, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Ucomfor Scientific Co.,ltd
Zhangjiagang Jiangsu, CN
Changzhou Careu Medical Instruments Co., Ltd.
Changzhou City Jiangsu, CN
Isomedix Operations Inc.
SAN DIEGO, CA, US
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Bard Sdn. Bhd.
KULIM Kedah, MY
Sterigenics U.s., Llc
Ontario, CA, US
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Changshu Beyond Medical Device Co., Ltd.
Changshu Jiangsu, CN
C.r. Bard, Inc.
COVINGTON, GA, US
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.
Shuyang Jiangsu, CN
Anhui Careplus Medical Technology Co., Ltd.
Xuancheng Anhui, CN
Innopex Limited
Toronto Ontario, CA
510(k) clearances
206 clearances for this product code
- Future Path Medical, LLCJun 24, 2011
K110518 · IBAG
- Maersk Medical A/SMar 17, 1998
K973364 · 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
- Medline Industries, Inc.Dec 11, 1997
K972887 · MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
- Urology Research Intl., Inc.Aug 18, 1997
K971271 · BESECURE EXTERNAL URINARY COLLECTION SYSTEM
- Amsino Intl., Inc.Aug 6, 1997
K971929 · AMSINO URINARY LEG BAG
- Welcon, Inc.Jul 29, 1997
K971764 · WELCON HUE-VU URINARY DRAINAGE BAG
- Cleveland Medical Devices, Inc.Mar 21, 1997
K964690 · LIBERTY VALVE
- Amsino Intl., Inc.Mar 18, 1997
K964745 · AMSINO URINARY DRAINAGE BAG