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U.S. Department of Health and Human Services

Class 2 Device Recall BD Microtainer Quikheel Lancet

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 Class 2 Recall
BD Microtainer Quikheel Lancet
see related information
Date Posted September 11, 2013
Recall Status1 Terminated on March 19, 2014
Recall Number Z-2192-2013
Recall Event ID 66031
Product Classification Lancet, Blood - Product Code FMK
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.
Code Information REF # 368101 Lot #3116007 Class I Exempt Device listing Number E158602
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
For Additional Information Contact Ms. Yogindra Dellow
201-847-5033
Manufacturer Reason
for Recall
The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action BD notified their customers and distributors by phone, e-mail, and/or letter/notice of return/ customer packing list on 7/10/2013.
Quantity in Commerce US - 39,800 units ; Canada - 18,400 units
Distribution Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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