Recall Z-1486-2013 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Coloplast Manufacturing US, LLC
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.
| Date | Jun 5, 2013 (initiated May 13, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 772 units |
| Distribution | US Distribution to: KY, MI, OH, PR, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120284 | DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX Coloplast A/S, May 23, 2012 |