Reported Jul 21, 2021 · Terminated
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am,…
Axonics Modulation Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Axonics Modulation Technologies, Inc. · 26 Technology Dr · Irvine, CA · 92618-2380
Is this the product you have?
- BULKAMID, URETHRAL BULKING SYSTEM model # 50050
- containing the component
Bulkamid NeedleREF 230651221C2 G x 12 amsterileCE 0476
- Lot codes and dates
- Lot numbers
19F0901AA19F0902AA19F0903AA19F0904AA19F0905AA19F0906AA
- Lot numbers
- Amount recalled
- 2,702 units
Where it was sold
- Nationwide
Why it was recalled
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
This product could cause temporary or reversible health problems — stop using it.
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