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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.

FDA Recall Z-2192-2013 · Posted 2013-09-11

Recall StatusTerminated
Product CodeFMK
Date Initiated2013-07-10
Date Terminated2014-03-19
Product QuantityUS - 39,800 units ; Canada - 18,400 units

Reason for Recall

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

Firm Action

BD notified their customers and distributors by phone, e-mail, and/or letter/notice of return/ customer packing list on 7/10/2013.

Root Cause

Component change control

Distribution Pattern

Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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