FDA Medical Device Recalls (openFDA)
Anika Therapeutics, Inc.: Amvisc Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY Product Numbr: 59081
- Recall number
- Z-1385-05
- Recalling firm
- Anika Therapeutics, Inc.
- Product
- Amvisc Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY Product Numbr: 59081
- Status
- Terminated
- Initiated
- 2005-07-14
- Posted
- 2005-08-23
- Terminated
- 2006-05-02
- Reason
- Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
- Root cause
- Other
- Action
- Anika Therapeutics notified Distributor accounts by telephone on July 14. The letters were faxed and sent by Fedex on July 14. Distributors were provided with a end-user letter template letter for notification to their accounts.
- Quantity
- not on file
- Distribution
- CA, NC
- Lot, serial or model codes
- Lot Numbers: B050510B, B050120B, B040616R
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LZP
- Firm FEI
- 3007093114
- Firm city
- Woburn
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28