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.
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- May 13, 2013
- Posted
- June 5, 2013
- Terminated
- April 10, 2014
- Recall Number
- Z-1486-2013
- Quantity
- 772 units
- Firm Location
- Minneapolis, MN
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.
Distribution
US Distribution to: KY, MI, OH, PR, TX, and VA.
Lot / Code Info
Lots 3390331, 3390339, 3390490.
Root Cause
Incorrect or no expiration date
Action Taken
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.
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