FDA Medical Device Recalls (openFDA)
Coloplast Manufacturing US, LLC: Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
- Recall number
- Z-0155-2015
- Recalling firm
- Coloplast Manufacturing US, LLC
- Product
- Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
- Status
- Terminated
- Initiated
- 2014-09-29
- Posted
- 2014-10-30
- Terminated
- 2015-03-10
- Reason
- Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
- Root cause
- Process control
- Action
- Consignees were sent a Coloplast "Recall Voluntary Notification " letter on 9-30-2014. The letter described the problem and the product affected by the recall. Requested consignees to complete the attached Acknowledgement Form and return to Coloplast or contact Coloplast Customer Service at 800-533-0464 to communicate the status of any product in their possession. If the product was distributed, they advised consignees to contact customers immediately and advise them of the recall and have them return the product to them. For questions they can contact Coloplast at Customer Service at 800-533-0464.
- Quantity
- 217,540
- Distribution
- Nationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.
- Lot, serial or model codes
- Lot Numbers: 3880261, 3880268, 3932929, 3932933, 3940329, 3940332, 3949825, 3949828, 3968997, 3969002, 3997492, 3997778, 3997782, 4006822, 4019572, 4019574, 4047072, 4047075, 4056422, 4056423, 4056428, 4073930, 4073934, 4092990, 4092991, 4100228.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NNW
- Firm FEI
- 2125050
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28