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U.S. Department of Health and Human Services

Class 2 Device Recall Digitex 20 Polydioxanone (PDO) suture

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 Class 2 Recall
Digitex 20 Polydioxanone (PDO) suture
see related information
Date Posted June 05, 2013
Recall Status1 Terminated on April 10, 2014
Recall Number Z-1486-2013
Recall Event ID 65314
Premarket Notification
510(K) Number
K120284 
Product Classification Suture, Absorbable, Synthetic, Polyglycolic Acid - Product Code GAM
Product Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
Code Information Lots 3390331, 3390339, 3390490.
Recalling Firm/
Manufacturer
Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis, Minnesota 55411-3431
Manufacturer Reason
for Recall
Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.
FDA Determined
Cause 2
EXPIRATION DATING: Incorrect or No Expiration Date
Action The firm, Coloplast, sent a letter dated May 8, 2013 to its customers. The letter described the problem, the product and actions to be taken. The customers will be contacted by Coloplast Customer Service with instructions for the handling and return of any unused product. If you have any additional questions, the dedicated Customer Service number regarding this effort is 800-258-3476.
Quantity in Commerce 772 units
Distribution US Distribution to: KY, MI, OH, PR, TX, and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GAM and Original Applicant = COLOPLAST A/S
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