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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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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
Distribution Pattern US Distribution to: KY, MI, OH, PR, TX, and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lots 3390331, 3390339, 3390490. Class II 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. 772 units Z-1486-2013