Z-0155-2015 Class II Terminated
FDA device recall Z-0155-2015 was initiated by Coloplast Manufacturing US, LLC on Sep 29, 2014 and is designated Class II. Reason for recall: Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled. The recall status is terminated (terminated Mar 10, 2015). Affected quantity: 217,540.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 5, 2014
- Initiation Date
- Sep 29, 2014
- Termination Date
- Mar 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 217,540
Product Description
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Reason for Recall
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
Distribution Pattern
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0155-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026