PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 5, 2014 Initiated: September 29, 2014 #Z-0155-2015

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.

Details

Units 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, WA, and WV.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.. Recalled by Coloplast Manufacturing US, LLC. Units affected: 217,540.
Why was this product recalled?
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 5, 2014. Severity: Moderate. Recall number: Z-0155-2015.