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U.S. Department of Health and Human Services

Class 3 Device Recall InterDry Ag

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 Class 3 Device Recall InterDry Agsee related information
Date Initiated by FirmJuly 21, 2009
Date PostedSeptember 04, 2009
Recall Status1 Terminated 3 on January 11, 2011
Recall NumberZ-1996-2009
Recall Event ID 52801
Product Classification Medical Absorbent Fiber - Product Code FRL
ProductColoplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distributed by Coloplast Corp Minneapolis MN 55411. InterDry" is a non-sterile, knitted, polyurethane-coated polyester textile impregnated with an antimicrobial silver complex used for the management of skin fold complications. The textile provides moisture transportation to keep skin dry while the antimicrobial in the textile reduces odor. The textile's low friction surface acts as a lubrication aid, thereby reducing skin-to-skin friction. InterDry" provides a protective environment for the skin and an effective protection against microbial contamination in the fabric. The product reduces colonization of the following gram-negative and gram-positive bacterial as well as yeast. Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa and Candida albicans. InterDry" Ag Textile contains 0.01% silver and is a single patient use product that is custom cut from a multi-use package.
Code Information Lot 1789435
FEI Number 2125337
Recalling Firm/
Manufacturer		 Coloplast Corp Skin Care Div
1940 Commerce Dr
North Mankato MN 56003-1700
For Additional Information Contact
507-345-6200
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionConsignees 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.
Quantity in CommerceUSA, 876 cases (10 rolls/case) ; Canada 53.9 cases (10 rolls/case)
DistributionWorldwide 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 and country of CANADA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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