FDA Recall
Terminated
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.
Recall: Z-2192-2013
·
Initiated July 10, 2013
Recall
- Recall Number
- Z-2192-2013
- Event Number
- 66031
- Firm
- Becton Dickinson & Company
- FEI Number
- 2243072
- Product Code
- FMK
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- July 10, 2013
- Posted
- September 11, 2013
- Terminated
- March 19, 2014
- Address
- 1 Becton Dr, Franklin Lakes, NJ, 07417-1815
Description
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.
Reason
The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
Action
BD notified their customers and distributors by phone, e-mail, and/or letter/notice of return/ customer packing list on 7/10/2013.
Distribution
Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.
Quantity
US - 39,800 units ; Canada - 18,400 units