Z-1058-05

#309604 -- 10 mL syringe

Name: Z-1058-05 #309604 -- 10 mL syringe
Creator: Becton Dickinson & Company
Published: 2005-05-25
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2005-05-25 / Terminated / root cause: sterility

FDA source

Becton Dickinson & Company began a recall of #309604 -- 10 mL syringe on 2005-05-25. The reason FDA records is "The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1058-05
Status: Terminated
Initiated: 2005-05-25
Posted: 2005-07-28
Terminated: 2005-12-02
Recalling firm: Becton Dickinson & Co
Product: #309604 -- 10 mL syringe
Product code: FMF Syringe, Piston
Reason for recall: The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
Root cause tag: sterility
FDA root cause: Other
Action: BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.
Quantity in commerce: 409200 units
Distribution: BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
Product codes and lots: 309604 10 ML Syringe 5074833

Product code FMF

K980987Class IIBecton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1998-06-11

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)