Axonics Modulation Technologies, Inc. recalls BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing
Recalled Product
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Hazard / Issue
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA
View official government recall
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