Z-1383-05

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

Name: Z-1383-05 ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000...
Creator: Anika Therapeutics, Inc.
Published: 2005-07-14
License: https://open.fda.gov/license/

Anika Therapeutics, Inc. / initiated 2005-07-14 / Terminated / root cause: packaging

FDA source

Anika Therapeutics, Inc. 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 2005-07-14. The reason FDA records is "Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1383-05
Status: Terminated
Initiated: 2005-07-14
Posted: 2005-08-23
Terminated: 2006-05-02
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: Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Root cause tag: packaging
FDA 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 in commerce: 3720 units
Distribution: CA, NC
Product codes and lots: Lot Numbers: B041118E, B041118F, B050510C

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)