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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Bard® Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Recall Number Z-1693-2014
Classification Class II
Code Info Lot Number: HUXH0688, HUXK0743, HUXL0803, HUXL0804
Product Distributed Qty
Reason For Recall Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Event Detail

Event Id 68124
Product Type Devices
Status Ongoing
Recalling Firm Davol, Inc., Subs. C. R. Bard, Inc.
City Warwick
State RI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM
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