Device 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.
Z-1486-2013
Product summary
- Event
- Event 65314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 772 units
- Official record key
device-enforcement:Z-1486-2013
Official wording
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.
Code information: Lots 3390331, 3390339, 3390490.
Distribution pattern: US Distribution to: KY, MI, OH, PR, TX, and VA.
Derived failure modes
-
Labeling or packaging
mislabeled