Recall Z-0191-2015 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Subs. C. R. Bard, Inc.
Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
| Date | Nov 7, 2014 (initiated Oct 8, 2014) |
| Status | Terminated |
| Reason | The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug. |
| Root cause | Error in labeling |
| Action | Davol Inc. (Subsidiary of C.R. Bard, Inc)sent Customer Notification letters on Friday, October 10, 2014, via FedEx next day delivery with signature confirmation to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this communication. A sample of the product labeling for the lot has been enclosed to assist in product code and lot number identification. The enclosure also depicts the supplied label as well as an image of the label with the correct |
| Quantity | 78 units |
| Distribution | US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 Davol Inc., Sub. C. R. Bard, Inc., Dec 8, 2009 |