Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product cod

FDA device recall Z-0243-04 · posted 2003-12-18 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.

Action taken

Cardinal Health notified all of their hospital accounts who ordered catalog PMII by letter dated 11/3/03, alerting them to the two lots identifed as counterfeit and requesting the accounts to place all lots on hold in quarantine until further instructions are received. The accounts were requested to call Cardinal Health Customer Service at 800-964-5227 to arrange for product replacement. Cardinal Health customers were sent a follow-up letter dated 11/11/03 with product disposition information, instructing them to return all products bearing lot numbers RBE609 and RJJ130 and all boxes of Prolene with orange dots on the end of the box to Cardinal Health, and to closely examine any remaining boxes to the labeling posted on Ethicon''s website www.Ethicon.com.

Root cause

Other

Status

Terminated

Product code

FTL

Quantity affected

365 boxes

Distribution

Nationwide

Date initiated

2003-11-03

Date posted

2003-12-18

Date terminated

2008-11-18

Location

Park, IL