Device product
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.
Z-2192-2013
Product summary
- Event
- Event 66031
- Status
- Terminated
- Classification
- Class II
- Quantity
- US - 39,800 units ; Canada - 18,400 units
- Official record key
device-enforcement:Z-2192-2013
Official wording
Reason: The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
Code information: REF # 368101 Lot #3116007 Class I Exempt Device listing Number E158602
Distribution pattern: Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.
Derived failure modes
-
Unknown
The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.