Class 2 Device Recall BD Microtainer Quikheel Lancet

• Date Initiated by Firm: July 10, 2013
• Date Posted: September 11, 2013
• Recall Status: 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 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: 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.