Z-1226-2007

ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of...

Name: Z-1226-2007 ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of...
Creator: Becton Dickinson & Company
Published: 2007-06-21
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2007-06-21 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin on 2007-06-21. The reason FDA records is "Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product". 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-1226-2007
Status: Terminated
Initiated: 2007-06-21
Posted: 2007-09-20
Terminated: 2008-06-03
Recalling firm: Becton Dickinson & Co
Product: ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.
Root cause tag: packaging
FDA root cause: Other
Action: Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.
Quantity in commerce: 644,500 units
Distribution: Nationwide.
Product codes and lots: Catalog number 326743, Batch number 6297350

Product code FMI

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)