Coloplast Manufacturing US, LLC: Medical Device Recall in 2013 - (Recall #: Z-1486-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 13, 2013

Date Posted: June 12, 2013

Recall Number: Z-1486-2013

Event ID: 65314

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.

Status: Terminated

Product Quantity: 772 units

Code Information:

Lots 3390331, 3390339, 3390490.

Distribution Pattern:

US Distribution to: KY, MI, OH, PR, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated