Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distri

FDA device recall Z-1996-2009 · posted 2009-09-04 · Terminated

Recall details

Recalling firm

Coloplast Corp Skin Care Div

Reason for recall

Coloplast determined that a portion of one lot of InterDry" Ag Lot number 1789435, did not meet the product specification for silver content. In this portion of the lot antimicrobial properties of the product could be compromised although the absorption and transportation of moisture would be as expected.

Action taken

Consignees were faxed on 7/27/09 a Coloplast "Product Recall" letter dated July 2009. The letter addressed the problem and requested consignees to contact Coloplast Customer Service at 1-800-533-0464 to communicate the status of the product. Replacement product will be provided upon receipt of returned product. It also advised distributors to contact their customers immediately and advise them of the recall and to return the product them. Questions or concerns should be directed to the customer's customer care rep at 1-800-533-0464.

Root cause

Process control

Status

Terminated

Product code

FRL

Quantity affected

USA, 876 cases (10 rolls/case) ; Canada 53.9 cases (10 rolls/case)

Distribution

Worldwide Distribution -- USA, including states of AL, AZ, CA, CT, FL, GA, IL, IN, IA, KY. LA, MI, MA,MO, MN, MS, MD, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI

Date initiated

2009-07-21

Date posted

2009-09-04

Date terminated

2011-01-11

Location

North Mankato, MN