Recall Z-0108-04 ยท LZP Aid, Surgical, Viscoelastic
Anika Therapeutics
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 | Nov 13, 2003 (initiated Oct 8, 2003) |
| Status | Terminated |
| Reason | Stability failure at the 20 month for viscosity specification |
| Root cause | Other |
| Action | Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers. |
| Quantity | 10,100 units |
| Distribution | CA, MO, NC,VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.