Skip to content
Recall Observatory FDA recall evidence

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

July 10, 2013

Class II

Product summary

Firm
Becton Dickinson & Company
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

    reason.no_named_rule · v1.0.0

    The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.