FDA Device

Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2" x 4", 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.

Hazard

Counterfeit product mixed with authentic product. The problem was recognized by the mismatching of expiration dates and the subtle differences in packaging.

What You Should Do

Remedy

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.

Products

Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2" x 4", 3 units per box, Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforce
Brand
Ram Medical Inc
UPC
Item Code: 0112650, Lot Numbers: 48HVS036 and 43APD007.

Units Affected

102 boxes of 3 units each