Bag, Bile Collecting
Gastroenterology, Urology · 21 CFR 876.5010
Recent MDR events
15 adverse event reports on file
- DRAINAGE BAGDec 24, 2025MalfunctionRemington Medical, Inc.23887814
- MERIT DRAINAGE DEPOT¿May 22, 2025MalfunctionMerit Medical Systems, Inc.1721504-2025-00039
- DRAINAGE BAG 600MLMay 19, 2021MalfunctionArgon Medical Devices, Inc.11847650
- 600 ML NAVARRE® UNIVERSAL GRAVITY DRAINAGE BAGApr 17, 2020MalfunctionBard Access Systems3006260740-2020-01430
- MERIT DRAINAGE DEPOT MDD600Dec 26, 2019InjuryMerit Medical, Systems, Inc.MW5091904
- DRAINAGE BAGNov 27, 2018MalfunctionArgon Medical Devices, Inc.8105550
- BARD NAVARRE UNIVERSAL GRAVITY DRAINAGE BAGJun 21, 2018MalfunctionBard Access Systems3006260740-2018-01472
- BAG, DRAINAGEJun 13, 2018MalfunctionArgon Medical Devices, Inc.7595916
- DRAINAGE BAGJun 11, 2018MalfunctionArgon Medical Devices, Inc.7586197
- DRAINAGE BAGJan 31, 2018MalfunctionArgon Medical Devices, Inc.7230174
Event type breakdown
Recalls
3 recall events for this product code
- Remington Medical, Inc.Open, ClassifiedDec 5, 2023
Remington MEDICAL Drainage Bag, REF 600-D;
There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
Z-0487-2024 · View FDA record ↗ - Remington Medical Inc.TerminatedJun 2, 2011
Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005.
There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
Z-2405-2011 · View FDA record ↗ - Remington Medical Inc.TerminatedOct 23, 2007
Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order num
Sterility, inadequate -- Pathway may not be sterile as labeled.
Z-0058-2008 · View FDA record ↗
Registered firms
39 firms currently registered for this product code
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
Medxl
ARDMORE, OK, US
Sterigenics Us Llc
Grand Prairie, TX, US
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
Cbr Enterprise Limited
Hong Kong, HK
Marlen Mfg. & Development Co.
BEDFORD, OH, US
C.r. Bard, Inc.
MADISON, GA, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Microtek Dominicana, S.a.s.
LA ROMANA, DO
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Merit Medical Systems, Inc.
South Jordan, UT, US
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Platinum Focus Group Ltd.
London London, City of, GB
Integra Biotechnical, Sa De Cv
Tijuana Baja California, MX
Argon Medical Devices Inc.
ATHENS, TX, US
Merit Medical Canada Ltd.
Markham Ontario, CA
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Isomedix Operations, Inc.
Minneapolis, MN, US
C.r. Bard, Inc.
COVINGTON, GA, US
Remington Medical, Inc.
ALPHARETTA, GA, US
Ad Supply Group Limited
London London, City of, GB
Isomedix Operations Inc.
SPARTANBURG, SC, US
510(k) clearances
9 clearances for this product code
- Merit Medical Systems, Inc.Dec 11, 2000
K003078 · MERIT DRAINAGE DEPOT
- Remington Medical, Inc.Aug 12, 1999
K990428 · DRAINAGE BAG
- Medical Device Technologies, Inc.Jan 30, 1998
K980005 · MANAN D BAG
- Manan Medical Products, Inc.Mar 13, 1997
K961986 · MANAN D BAG
- Manan Medical Products, Inc.Dec 13, 1996
K963849 · MANAN D BAG
- Navarre Biomedical , Ltd.Sep 8, 1994
K943663 · NAVARRE 600 ML DRAINAGE BAG
- Medical Technologies of GeorgiaAug 7, 1991
K911129 · MMG BILE BAG
- Uresil Corp.Sep 12, 1990
K903449 · URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET