Z-1996-2009

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

Name: Z-1996-2009 Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek...
Creator: Coloplast Corp Skin Care Div
Published: 2009-07-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2009-07-21 / Terminated / root cause: manufacturing process

FDA source

Coloplast Corp Skin Care Div began a recall of Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distributed by Coloplast Corp Minneapolis MN... on 2009-07-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1996-2009
Status: Terminated
Initiated: 2009-07-21
Posted: 2009-09-04
Terminated: 2011-01-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Coloplast, 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.
Product code: FRL Fiber, Medical, Absorbent
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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 and country of CANADA.
Product codes and lots: Lot 1789435

Product code FRL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)