—#121295

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.

FDA product code: FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: REF # 368101 Lot #3116007 Class I Exempt Device listing Number E158602

Why it was recalled

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

Root cause (FDA determination)

Component change control

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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

Timeline

Recall initiated: 2013-07-10
Posted by FDA: 2013-09-11
Terminated: 2014-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121295. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.