FDAFDA · Food and drugs·Recall number Z-1486-2013
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.
Published June 12, 2013 · Recall initiated: May 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Coloplast Manufacturing US, LLC
- Distributor
- US Distribution to: KY, MI, OH, PR, TX, and VA.
- Lot
- Lots 3390331, 3390339, 3390490.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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