Bulkamid recall: Sterility Concern
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Why was Bulkamid recalled?
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA
- Product
- BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
- Recalling firm
- Axonics Modulation Technologies, Inc.
- Quantity
- 2,702 units
- Distribution
- US nationwide distribution.
- Recall date
- July 21, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)