Coloplast Manufacturing US, LLC: Medical Device Recall in 2014 - (Recall #: Z-0155-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 29, 2014

Date Posted: November 5, 2014

Recall Number: Z-0155-2015

Event ID: 69412

Reason for Recall:

Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.

Status: Terminated

Product Quantity: 217,540

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated