FDA-Device2013-09-18Class II

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.

Becton Dickinson & Company
Hazard

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

Sold states
Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.
Affected count
US - 39,800 units ; Canada - 18,400 units
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2192-2013

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