Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Deli
FDA device recall Z-1486-2013 · posted 2013-06-05 · Terminated
Recall details
- Recalling firm
- Coloplast Manufacturing US, LLC
- 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.
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 772 units
- Distribution
- US Distribution to: KY, MI, OH, PR, TX, and VA.
- Date initiated
- 2013-05-13
- Date posted
- 2013-06-05
- Date terminated
- 2014-04-10
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX (K120284) | Coloplast A/S | 2012-05-23 |