Z-0346-04

Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only...

Name: Z-0346-04 Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only...
Creator: Cardinal Health
Published: 2003-12-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-12-11 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health began a recall of Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia... on 2003-12-11. The reason FDA records is "The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0346-04
Status: Terminated
Initiated: 2003-12-11
Posted: 2004-01-14
Terminated: 2004-04-08
Recalling firm: Medtronic, Inc.
Product: Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.
Product code: HMX Cannula, Ophthalmic
Reason for recall: The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm contacted their consignees on 12/11/2003 by telephone and letter.
Quantity in commerce: 110 vials
Distribution: The product was distributed to customers in OH and PA.
Product codes and lots: Lots: #5047293 and #5048892

Product code HMX

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)