Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc.

FDA device recall Z-1649-2010 · posted 2010-06-08 · Terminated

Recall details

Recalling firm

Ram Medical Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FTL

Quantity affected

135 boxes of lor 43HPD027, 25 boxes of 43HPD032; 42 boxes of HUSG0540

Distribution

Nationwide Distribution -- CO, IL , NY, MO and FL.

Date initiated

2010-03-05

Date posted

2010-06-08

Date terminated

2016-06-06

Location

Wayne, NJ