Recall Z-1383-05 ยท LZP Aid, Surgical, Viscoelastic
Anika Therapeutics, Inc.
ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
| Date | Aug 23, 2005 (initiated Jul 14, 2005) |
| Status | Terminated |
| 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 | 3720 units |
| Distribution | CA, NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.