Recall Z-2192-2013 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Becton Dickinson & Company
BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.
| Date | Sep 11, 2013 (initiated Jul 10, 2013) |
| Status | Terminated |
| Reason | The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. |
| Root cause | Component change control |
| Action | BD notified their customers and distributors by phone, e-mail, and/or letter/notice of return/ customer packing list on 7/10/2013. |
| Quantity | US - 39,800 units ; Canada - 18,400 units |
| Distribution | Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.