Recall Z-1649-2010 ยท FTL Mesh, Surgical, Polymeric
Ram Medical Inc
Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.
| Date | Jun 8, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| Reason | Counterfeit product mixed with authentic product. The problem was recognized by the mismatching of expiration dates and the subtle differences in packaging. |
| Root cause | Nonconforming Material/Component |
| Action | Ram Medical Inc., contacted Customers by phone beginning March 4, 2010 and issued "Urgent Device Recall" notifications beginning March 8, 2010. Further notifications were issued to expand the scope of the recall by the firm. Each notification described the affected product and asked the User to complete a Recall Acknowledgement Form and return it to the firm. All affected product should be returned to the firm. For further information, contact Ram Medical, Inc. at 1-973-633-0400 Monday through Friday, 9:00 AM to 5:00 PM EST. |
| Quantity | 135 boxes of lor 43HPD027, 25 boxes of 43HPD032; 42 boxes of HUSG0540 |
| Distribution | Nationwide Distribution -- CO, IL , NY, MO and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.