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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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  Class 2 Device Recall BD see related information
Date Initiated by Firm August 02, 2016
Create Date November 10, 2016
Recall Status1 Terminated 3 on April 22, 2019
Recall Number Z-0394-2017
Recall Event ID 75150
Product Classification Anesthesia conduction kit - Product Code CAZ
Product catalog # 405612
BD Spinal Anesthesia Tray
22G x 3.5 in. BD" Quincke Spinal Needle
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog # 405622
BD Spinal Anesthesia Tray
25G x 3.5 in. BD" Quincke Spinal Needle
Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine)
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL


catalog # 405623
BD Spinal Anesthesia Tray
25G x 3.5 in. BD" Quincke Spinal Needle
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog #405624
BD Spinal Anesthesia Tray
25G x 3.5 in. BD" Quincke Spinal Needle
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog # 405634
BD Spinal Anesthesia Tray
26G x 3.5 in. BD" Quincke Spinal Needle
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog # 405636
BD Spinal Anesthesia Tray
26G x 3.5 in. BD" Quincke Spinal Needle
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog #405641
BD Spinal Anesthesia Tray
24G x 3.5 in. Sprotte¿ Needle
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog #405648
BD Spinal Anesthesia Tray
22G x 3.5 in. BD" Whitacre Spinal Needle
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog# 405649
BD Spinal Anesthesia Tray
22G x 3.5 in. BD" Whitacre Spinal Needle
25G x 3.5 in. BD" Quincke Spinal Needle
Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine)
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL


catalog # 405682
BD Spinal Anesthesia Tray
25G x 3.5 in. BD" Whitacre Spinal Needle, TW
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog #405684
BD Spinal Anesthesia Tray
25G x 3.5 in. BD" Whitacre Spinal Needle, TW
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog #405685
BD Spinal Anesthesia Tray
25G x 3.5 in. BD" Whitacre Spinal Needle, TW
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL


catalog#405694
BD Spinal Anesthesia Tray
25G x 3.5 in. BD" Quincke Spinal Needle
25G x 3.5 in. BD" Whitacre Spinal Needle, TW
Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine)
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL


catalog #405704
BD Spinal Anesthesia Tray
27G x 3.5 in. BD" Whitacre Spinal Needle
Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL

catalog #405737
BD Spinal Anesthesia Tray
25G x 3.5 in. BD" Whitacre Spinal Needle, TW
Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine)

catalog# 405829
BD Spinal Anesthesia Tray
27G x 3.5 in. BD" Quincke Spinal Needle
25G x 3.5 in. BD" Whitacre Spinal Needle, TW
Code Information 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B03H034D 1-May-2015 B04J262D 1-Oct-2016   25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H034D 1-May-2015 B01H238D 1-Jan-2016 B01H259D 1-Jan-2016 B02J229D 1-Oct-2016 B03J364D 1-Oct-2016 B03K006D 1-Oct-2016 B03K048D 1-Oct-2016 B04H136D 1-Sep-2015  BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H035D 1-May-2015 B01H036D 1-May-2015 B01H070D 1-Jun-2015 B01H091D 1-Jun-2015 B01H138D 1-Sep-2015 B02H031D 1-May-2015 B04H119D 1-Jun-2015  BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H191D 1-Oct-2016 B02H135D 1-Oct-2016 B03H050D 1-Jul-2016 B03H114D 1-Oct-2016   27G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B02H034D 1-May-2015   25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) B03H153D 1-Sep-2015   27G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW B02H077D 1-Jun-2015 B03H106D 1-Jun-2015
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
201-847-6800
Manufacturer Reason
for Recall		 A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul, NDC # 0409-4712-01. Some BD" Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD Spinal Trays.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action BD sent recall letters/business reply card was sent via UPS/email on 8/2/2016. Stericycle is handling returns.
Quantity in Commerce 39,130 trays
Distribution Nationwide.
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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