ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed
FDA device recall Z-1383-05 · posted 2005-08-23 · Terminated
Recall details
- Recalling firm
- Anika Therapeutics, Inc.
- Reason for recall
- Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZP
- Quantity affected
- 3720 units
- Distribution
- CA, NC
- Date initiated
- 2005-07-14
- Date posted
- 2005-08-23
- Date terminated
- 2006-05-02
- Location
- Woburn, MA
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