Z-0155-2015Class II

Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag

Name: Z-0155-2015 Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag
Creator: Coloplast Manufacturing US, LLC
Published: 2014-09-29
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2014-09-29 / Terminated / root cause: manufacturing process

FDA source

Coloplast Manufacturing US, LLC began a recall of Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag on 2014-09-29. FDA classified it as Class II and gives the reason as "Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0155-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-29
Posted: 2014-10-30
Terminated: 2015-03-10
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Product code: NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile
Reason for recall: Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0155-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0155-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-30

Product code NNW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)