Class I Medical Device Recall: Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol
Company, Product(s): Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol
Recall Class: Class I
Date Recall Initiated: March 5, 2010
Product Names: Various sizes of counterfeit flat sheets of polypropylene surgical mesh have been marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes, specifically identified below, are NOT Bard-manufactured products. These counterfeit products were distributed October 21, 2008 to October 27, 2009.
|Product Codes and Sizes||Lot Numbers|
|0112650 Ã¢?" Bard Flat Mesh 2" x 4"||Lot 48HVS036
|0112660 Ã¢?" Bard Flat Mesh 10" x 14"||Lot HUSD0629
|0112680 Ã¢?" Bard Flat Mesh 3" x 6"||Lot 43HPD027
|0112720 Ã¢?" Bard Flat Mesh 6" x 6"||Lot 43FQD327|
Use: Surgical meshes of this kind are used to reinforce soft tissue where weakness exists.
RAM Medical, Inc.
4 Haul Rd
Wayne, NJ 07470-6625
Reason for Recall: The product was deemed a counterfeit. The product does not meet manufacturerÃ¢??s specifications. Discrepancies were found in the expiration dates, for example, in some packaging the date on the package states 2011-05, but it does not match the date on the top lip of the product box that reads 2010-01.
Public Contact: Questions should be directed to RAM Medical at (973)-633-0400 Monday through Friday from 9:00 a.m. to 5 p.m. Eastern Time.
FDA District: New Jersey
FDA Comments: RAM Medical Inc., the distributor, notified their distributors of the voluntary recall with a letter dated March 5, 2010.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.