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U.S. Department of Health and Human Services

Class 2 Device Recall PROLENE

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  Class 2 Device Recall PROLENE see related information
Date Initiated by Firm October 31, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 04, 2011
Recall Number Z-0249-04
Recall Event ID 27682
Product Classification Mesh, Surgical, Polymeric - Product Code FTL
Product PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton
Code Information All codes, including the lots that the manufacturer of authentic product specified as counterfeit, RBE609 EXP1/07 and RJJ130 EXP 7/07.
Recalling Firm/
Manufacturer		 McKesson General Medical Corporation
5601 Eastport Boulevard
Richmond VA 23231
For Additional Information Contact Cathy DeLesDernier
804-264-7766
Manufacturer Reason
for Recall		 Counterfeit product is an unapproved medical device with associated potential health hazard.
FDA Determined
Cause 2		 Other
Action The distributor notified all distribution centers and field personnel by e-mail on 10/29/03. The firm''s centers were instructed to inspect and quarantine lots RBE609 and RJJ130. Field personnel were instructed to notify customers to quarantine counterfeit product and any suspect product. On 10/30/03, the recalling distributor notified its field representatives to inspect and quarantine all lots of the mesh. The firm issued a recall notification with reply form to all consignees receiving surgical mesh product since Jan 03.
Quantity in Commerce 180 cartons
Distribution Counterfeit and authentic product had been shipped to 221 hospitals and surgery centers in the continental US.
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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