Z-1486-2013 Class II Terminated
FDA device recall Z-1486-2013 was initiated by Coloplast Manufacturing US, LLC on May 13, 2013 and is designated Class II. 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. The recall status is terminated (terminated Apr 10, 2014). Affected quantity: 772 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2013
- Initiation Date
- May 13, 2013
- Termination Date
- Apr 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 772 units
Product 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 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 Pattern
US Distribution to: KY, MI, OH, PR, TX, and VA.
Code Information
Lots 3390331, 3390339, 3390490.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1486-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026