Z-0569-05

ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23

Name: Z-0569-05 ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23
Creator: Becton Dickinson & Company
Published: 2004-10-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2004-10-22 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23 on 2004-10-22. The reason FDA records is "Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga)". 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-0569-05
Status: Terminated
Initiated: 2004-10-22
Posted: 2005-03-03
Terminated: 2006-04-14
Recalling firm: Becton Dickinson & Co
Product: ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23.
Product code: FMF Syringe, Piston
Reason for recall: Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: BD has sent letters to the distributor McKesson Inc and the retailer Wal-Mart Inc.
Quantity in commerce: 1543000 syringes
Distribution: The syringes were sent to McKesson Corp, 120 Senlac Drive, Carrollton, TX 75006 who then sold them to Wal-Mart Corp, 702 SW 8th Street, Bentonville, AR 72716. There are no other customers.
Product codes and lots: Batch # 4083690

Product code FMF

K955235Class IIB-D Ultra Fine II, Micro Fine + Short Needle Insulin SyringeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1996-02-12

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)