Z-1688-2014 Class II Terminated

Recalled by Davol, Inc., Subs. C. R. Bard, Inc. — Warwick, RI

Recall Details

Product Type
Devices
Report Date
June 11, 2014
Initiation Date
April 24, 2014
Termination Date
December 23, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Reason for Recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

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

Code Information

Lot Number: HUYA1057