Axonics Modulation Technologies, Inc. recalls BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am,…
- Recall date
- June 3, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2077-2021
- FDA classification
- Class II
- Brand / firm
- Axonics Modulation Technologies, Inc.
- Sold / distributed
- US nationwide distribution.
Why it was recalled
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
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