Z-0802-03

Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial...

Name: Z-0802-03 Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial...
Creator: Hu-Friedy Mfg Co, Inc.
Published: 2003-04-10
License: https://open.fda.gov/license/

HU-Friedy Mfg. Co. LLC / initiated 2003-04-10 / Terminated / root cause: labeling and UDI

FDA source

Hu-Friedy Mfg Co, Inc. began a recall of Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N... on 2003-04-10. The reason FDA records is "The suture needles were mislabeled with the wrong size". 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-0802-03
Status: Terminated
Initiated: 2003-04-10
Posted: 2003-05-09
Terminated: 2004-03-24
Recalling firm: HU-Friedy Mfg. Co. LLC
Product: Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618
Product code: GAB--
Reason for recall: The suture needles were mislabeled with the wrong size.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Hu-Friedy sent recall letters dated 4/10/03 to their accounts on the same date, informing them that the incorrect size needle was packaged as SN4 suture needles, and requesting them to quarantine all warehouse stocks of SN4 suture needles for return to Hu-Friedy for replacement and to notify their sub-accounts.
Quantity in commerce: 200 vials
Distribution: Michigan, Massachusetts, California, Pennsylvania, Texas, Washington, New York, Wisconsin, Iowa, Indiana, Tennessee, New Jersey, Louisiana, South Carolina, Florida, and internationally to Canada, Australia and New Zealand.
Product codes and lots: Partcode SN4, all units distributed between 1/3/01 and 3/10/03.

Product code GAB--

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)