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Terminated

Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 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.

FDA Recall Z-1648-2010 · Posted 2010-06-08

Recalling FirmRam Medical Inc
Recall StatusTerminated
Product CodeFTL
Date Initiated2010-03-05
Date Terminated2016-06-06
Product Quantity9 boxes of 3 units each.

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution -- CO, IL , NY, MO and FL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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