Z-0108-04

ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000...

Name: Z-0108-04 ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000...
Creator: Anika Therapeutics
Published: 2003-10-08
License: https://open.fda.gov/license/

Anika Therapeutics, Inc. / initiated 2003-10-08 / Terminated

FDA source

Anika Therapeutics began a recall of ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC on 2003-10-08. The reason FDA records is "Stability failure at the 20 month for viscosity specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0108-04
Status: Terminated
Initiated: 2003-10-08
Posted: 2003-11-13
Terminated: 2004-08-09
Recalling firm: Anika Therapeutics, Inc.
Product: ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC
Product code: LZP Aid, Surgical, Viscoelastic
Reason for recall: Stability failure at the 20 month for viscosity specification
FDA 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 in commerce: 10,100 units
Distribution: CA, MO, NC,VA
Product codes and lots: Lot Number: B020122B

Product code LZP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)