Recall Z-1695-2014 ยท GCJ Laparoscope, General & Plastic Surgery
Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
| Date | Jun 2, 2014 (initiated Apr 24, 2014) |
| Status | Terminated |
| Reason | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. |
| Root cause | Packaging process control |
| Action | Davol, Inc., Subs. C. R. Bard, Inc.sent an Urgent Medical Device Recall letter dated April 28, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory and quarantine product subject to the recall, contact Davol Customer Service at 1-800-556-6275 or C.R. Bard's Medical Services and Support Department at 1-800-562-0027 for instructions on how to return the product to Davol, Consignees were also instructed to complete and return the recall effectiveness check form, and |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122436 | COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. Bard, Inc., Nov 2, 2012 |