Recall Z-0044-2008 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Becton Dickinson & Company
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
| Date | Oct 18, 2007 (initiated Sep 26, 2007) |
| Status | Terminated |
| Reason | 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 | Process design |
| Action | Recall communication issued on or about 9/28/2007. |
| Quantity | 1,476,000 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.