FDAFDA · Food and drugs·Recall number Z-1688-2014
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.
Published June 11, 2014 · Recall initiated: April 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Davol, Inc., Subs. C. R. Bard, Inc.
- Distributor
- 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
- Lot
- Lot Number: HUYA1057
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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