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Class I Medical Device Recall: Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol

Tue, 06/08/2010 - 10:38am
U.S. Food & Drug Administration

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 â?" Bard Flat Mesh 2" x 4" Lot 48HVS036

Lot 43APD007

0112660 â?" Bard Flat Mesh 10" x 14" Lot HUSD0629

Lot HURL0336

0112680 â?" Bard Flat Mesh 3" x 6" Lot 43HPD027

Lot 43HPD032

Lot 43HPD034

Lot HUSG0540

Lot 43HDP027

Lot HUSE0532

Lot 43LPD507

Lot HUSF0763

Lot 43IOD011

Lot 43IPD038

0112720 â?" Bard Flat Mesh 6" x 6" Lot 43FQD327

Use: Surgical meshes of this kind are used to reinforce soft tissue where weakness exists.

Distributor:

RAM Medical, Inc.

4 Haul Rd

Wayne, NJ 07470-6625

Reason for Recall: The product was deemed a counterfeit. The product does not meet manufacturerâ??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.

On March 11, 2010 an FDA Initial Communication and an FDA News Release were issued alerting health care facilities and health care professionals about the existence of these counterfeit products.

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.

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