Z-1486-2013Class II

Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The...

Name: Z-1486-2013 Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The...
Creator: Coloplast Manufacturing US, LLC
Published: 2013-05-13
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2013-05-13 / Terminated / root cause: labeling and UDI

FDA source

Coloplast Manufacturing US, LLC began a recall of Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable... on 2013-05-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1486-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-13
Posted: 2013-06-05
Terminated: 2014-04-10
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: 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.
Quantity in commerce: 772 units
Distribution: US Distribution to: KY, MI, OH, PR, TX, and VA.
Product codes and lots: Lots 3390331, 3390339, 3390490.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1486-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1486-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05

Product code GAM

K120284Class IIDigitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with Needle and without Needle, DigitexColoplast A/S / cleared 2012-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)