Z-0480-2011

GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog #...

Name: Z-0480-2011 GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog #...
Creator: Becton Dickinson & Co.
Published: 2010-08-13
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-08-13 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and... on 2010-08-13. The reason FDA records is "In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples". 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-0480-2011
Status: Terminated
Initiated: 2010-08-13
Posted: 2010-11-26
Terminated: 2011-01-05
Recalling firm: Becton Dickinson & Co
Product: GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA***
Product code: KZJ Device, Gas Generating
Reason for recall: In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BD Diagnostic Systems issued an Urgent Product Recall letter dated August 2010 to consignees. Consignees were advised of the defect and were requested to discard product for replacement. Distributors were additionally requested to provide distribution lists of end users for direct BD notification. Accounts were requested to return a response form. BD Customer Service can be contacted at 800 675-0908, and BD Technical Services can be contacted at 800-638-8663.
Quantity in commerce: 496 units
Distribution: Worldwide Distribution: USA and the countries of Australila, Belgium, Canada, India, Mexico, New Zealand. Singapore, and South Korea,
Product codes and lots: Batch No. 7110573

Product code KZJ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)