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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Recall Number Z-1296-2014
Classification Class II
Code Info Product Code: X-6371M5, Lot numbers: 02E0801603
Product Distributed Qty Total 32,271 ea.
Reason For Recall The products are being recalled because they did not meet minimum needle attachment strength requirements.

Event Detail

Event Id 67733
Product Type Devices
Status Ongoing
Recalling Firm Teleflex Medical
City Research Triangle Park
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland