FDA-Device2021-07-21Class II
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Axonics Modulation Technologies, Inc.
Hazard
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Sold states
US nationwide distribution.
Affected count
2,702 units
Manufactured in
26 Technology Dr, Irvine, CA, United States
Products
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2021Don't want to check this manually?
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