Z-1682-2014 Class II Terminated
FDA device recall Z-1682-2014 was initiated by Davol, Inc., Subs. C. R. Bard, Inc. on April 24, 2014 and is designated Class II. Reason for recall: Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. The recall status is terminated (terminated December 23, 2015).
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
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 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
HUXH0294, HUXL0314