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.
Reported: June 12, 2013 Initiated: May 13, 2013 #Z-1486-2013
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.
Details
- Recalling Firm
- Coloplast Manufacturing US, LLC
- Units Affected
- 772 units
- Distribution
- US Distribution to: KY, MI, OH, PR, TX, and VA.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Coloplast Manufacturing US, LLC. Units affected: 772 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2013. Severity: Moderate. Recall number: Z-1486-2013.
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