Reported Jun 12, 2013 · Terminated
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex…
Coloplast Manufacturing US, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Coloplast Manufacturing US, LLC · 1601 W River Rd · Minneapolis, MN · 55411-3431
Is this the product you have?
- Digitex Absorbable Polydiaxanone Suture, Size 2-0
- Catalog Number / Code of product52031, 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
- Lot codes and dates
Lots 339033133903393390490
- Amount recalled
- 772 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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