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U.S. Department of Health and Human Services

Class 1 Device Recall Bard Mesh Monofilament Knitted Polypropylene

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  Class 1 Device Recall Bard Mesh Monofilament Knitted Polypropylene see related information
Date Initiated by Firm March 05, 2010
Date Posted June 08, 2010
Recall Status1 Terminated 3 on June 06, 2016
Recall Number Z-1649-2010
Recall Event ID 54884
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product 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.
Code Information Item Code: 0112680, Lot Numbers: 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43HPD034.
Recalling Firm/
Manufacturer		 Ram Medical Inc
4 Haul Rd
Wayne NJ 07470-6625
For Additional Information Contact Michael Neuhaus
973-633-0400
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 135 boxes of lor 43HPD027, 25 boxes of 43HPD032; 42 boxes of HUSG0540
Distribution Nationwide Distribution -- CO, IL , NY, MO and FL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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