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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

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.
Recall Number Z-1486-2013
Classification Class II
Code Info Lots 3390331, 3390339, 3390490.
Product Distributed Qty 772 units
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.

Event Detail

Event Id 65314
Product Type Devices
Status Ongoing
Recalling Firm Coloplast Manufacturing US, LLC
City Minneapolis
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution to: KY, MI, OH, PR, TX, and VA.