Z-1488-2009

BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661

Name: Z-1488-2009 BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661
Creator: Becton Dickinson & Company
Published: 2009-04-30
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-04-30 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661 on 2009-04-30. The reason FDA records is "Potential for compromised sterility: Insufficient packaging seals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1488-2009
Status: Terminated
Initiated: 2009-04-30
Posted: 2009-06-24
Terminated: 2009-09-28
Recalling firm: Becton Dickinson & Co
Product: BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661.
Product code: FMF Syringe, Piston
Reason for recall: Potential for compromised sterility: Insufficient packaging seals.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Becton Dickinson sent Urgent Product Recall letters on April 30, 2009 to all direct customers. Questions are to be directed to BD Customer Service at 1-888-237-2762. Letters to customers of distributors went out on May 12, 2009.
Quantity in commerce: 201,600 units
Distribution: Nationwide Distribution.
Product codes and lots: Catalog Number 309661: Lot numbers: 9065361, 9065362, 9065366, 9065367, 9065380.

Product code FMF

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)