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U.S. Department of Health and Human Services

Medical Devices

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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 – Bard Flat Mesh 2" x 4" Lot 48HVS036
Lot 43APD007
0112660 – Bard Flat Mesh 10" x 14" Lot HUSD0629
Lot HURL0336
0112680 – 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 – 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 manufacturer'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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