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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 Device Recall BD Microtainer Quikheel Lancet see related information
Date Initiated by Firm July 10, 2013
Date Posted September 11, 2013
Recall Status1 Terminated 3 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 NJ 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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