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

FDA device recall Z-0155-2015 · posted 2014-10-30 · Terminated

Recall details

Recalling firm

Coloplast Manufacturing US, LLC

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

NNW

Quantity affected

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,

Date initiated

2014-09-29

Date posted

2014-10-30

Date terminated

2015-03-10

Location

Minneapolis, MN