catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in
Medical device recall Z-0394-2017. Published in FDA’s Enforcement Report on Nov 16, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 16, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 39,130 trays how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
39,130 trays, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,298 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 2, 2016.
- FDA classified it on Nov 10, 2016.
- FDA’s Enforcement Report published it on Nov 16, 2016.
- FDA terminated it on Apr 22, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Becton Dickinson & Company, of Franklin Lakes, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.