Z-0046-2008

Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width...

Name: Z-0046-2008 Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width...
Creator: Becton Dickinson & Company
Published: 2007-09-26
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2007-09-26 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton Dickinson Vacutainer Systems Becton... on 2007-09-26. The reason FDA records is "Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal". 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-0046-2008
Status: Terminated
Initiated: 2007-09-26
Posted: 2007-10-18
Terminated: 2008-01-15
Recalling firm: Becton Dickinson & Co
Product: Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton Dickinson Vacutainer Systems Becton dickinson and COmpany; Franklin Lakes, NJ 07417
Product code: F
Reason for recall: Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Recall communication issued on or about 9/28/2007.
Quantity in commerce: 4,349,000 units
Distribution: Product distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.
Product codes and lots: Catalog number 366357; Lot numbers: 2228742; 3022532; 3037536; 3055877; 3062548; 3079392; 3086096; 3135003; 3142723; 3199645; 3225646; 3240751; 3248047; 3268651; 2323030; 2330450.

Product code F

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)