Davol, Inc., Subs. C. R. Bard, Inc. recalls Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficienci

Recalled June 11, 2014 · FDA recall Z-1682-2014 · Davol, Inc., Subs. C. R. Bard

Hazard

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

Sold at

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

Description

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

Product

Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Manufacturer(s)

Davol, Inc., Subs. C. R. Bard, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →