Z-1690-2014 Class II Terminated
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" 4"x6" Reorder Number: 5955460 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: HUXH0695