—#64557

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

FDA product code: F
Affected lot / code info: Catalog number 366357; Lot numbers: 2228742; 3022532; 3037536; 3055877; 3062548; 3079392; 3086096; 3135003; 3142723; 3199645; 3225646; 3240751; 3248047; 3268651; 2323030; 2330450.

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

Recall communication issued on or about 9/28/2007.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-09-26
Posted by FDA: 2007-10-18
Terminated: 2008-01-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64557. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.