BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

Reason: Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized

Code information: Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA

Distribution pattern: US nationwide distribution.