FDA Enforcement
Class II
Terminated
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.
Recall: Z-1486-2013
·
Reported June 12, 2013
Enforcement
- Recall Number
- Z-1486-2013
- Event ID
- 65314
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Coloplast Manufacturing US, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2013
- Initiation Date
- May 13, 2013
- Classification Date
- June 5, 2013
- Termination Date
- April 10, 2014
- Address
- 1601 W River Rd, N/A, Minneapolis, MN, 55411-3431, United States
Description
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.
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 Info
Lots 3390331, 3390339, 3390490.
Distribution
US Distribution to: KY, MI, OH, PR, TX, and VA.
Quantity
772 units