Recalls / —
—#64555
Product
Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
- FDA product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Catalog Number 366356 Lot numbers: 2340296, 2353789, 3007400, 3043001, 3073415, 3100407, 3198493.
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 #64555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.