Z-0174-2012

1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920

Name: Z-0174-2012 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920
Creator: Becton Dickinson & Company
Published: 2011-06-15
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-06-15 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin on 2011-06-15. The reason FDA records is "Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes". 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-0174-2012
Status: Terminated
Initiated: 2011-06-15
Posted: 2011-11-07
Terminated: 2015-07-27
Recalling firm: Becton Dickinson & Co
Product: 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin.
Product code: KZH Introducer, Syringe Needle
Reason for recall: Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, BD, sent an "PRODUCT RECALL NOTIFICATION" letter and response form dated June 15, 2011 to their consignee/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately review their inventory for the affected product, remove the product from inventory, quarantine the product and return it to BD; if the product was further distributed, they should identify their customers and notify them at once, and complete and return the attached Tracking/Verification Form via fax to: 201-847-4853. If you have any questions, contact Customer Service at 1-800-237-2762, Monday -Thursday, 8:00am-6:30pm and on Friday, 8:00-5:30pm Eastern Standard Time.
Quantity in commerce: 10,230 shelf cartons (1,0230,000 syringes)
Distribution: Nationwide Distribution.
Product codes and lots: K024112 D039612 Catalog Number 329424 Lot Number 0039920

Product code KZH

K024112Class IIBd Insulin SyringeBecton, Dickinson & CO / cleared 2003-01-09

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)