BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Reported: July 21, 2021 Initiated: June 3, 2021 #Z-2077-2021
Product Description
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Reason for Recall
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Details
- Recalling Firm
- Axonics Modulation Technologies, Inc.
- Units Affected
- 2,702 units
- Distribution
- US nationwide distribution.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476. Recalled by Axonics Modulation Technologies, Inc.. Units affected: 2,702 units.
Why was this product recalled? ▼
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 21, 2021. Severity: Moderate. Recall number: Z-2077-2021.
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