FDA-Device2013-06-12Class II
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.
Coloplast Manufacturing US, LLC
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.
Sold states
US Distribution to: KY, MI, OH, PR, TX, and VA.
Affected count
772 units
Manufactured in
1601 W River Rd, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1486-2013Don't want to check this manually?
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