The Recall Desk
ModerateFDA (Devices)·Z-0394-2017·Announced 2016-11-16

Becton Dickinson Recalls Spinal Anesthesia Trays Containing Recalled Lidocaine

Becton Dickinson is recalling specific BD Spinal Anesthesia Trays because they contain Hospira 5% Lidocaine HCI ampules that are subject to a separate recall.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. It is a precautionary measure to remove trays containing a separately recalled drug component, with no specific injuries or illnesses reported in this notice.

Plain-English summary

Becton Dickinson & Company is recalling specific lots of BD Spinal Anesthesia Trays. This action is taken because some of these trays contain 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC # 0409-4712-01), which are being recalled by Hospira, Inc.

The recall affects 39,130 trays distributed nationwide. The affected trays include various catalog numbers containing 22G, 24G, 25G, 26G, or 27G spinal needles (Quincke, Whitacre, or Sprotte types) paired with the specific Lidocaine ampules. Specific lot codes and expiration dates are listed in the official recall documentation.

Healthcare facilities and distributors should check their inventory for the affected catalog numbers and lot codes. If the trays contain the recalled Hospira Lidocaine ampules, they should be removed from use and returned to Becton Dickinson according to their instructions.

The recalled product

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 (Marca
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Spinal Anesthesia Trays
Hazard
Affected units
39,130

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 25G x 3.5 in. BD" Whitacre Spinal Needle
  • TW Lidocaine HCL (5%) with Dextrose (7.5%)
  • TW Bupivacaine HCL (0.75%) with Dextrose (8.25%)
  • 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%)
  • 2 mL B02H034D 1-May-2015 25G x 3.5 in. BD" Whitacre Spinal Needle
  • TW B02H077D 1-Jun-2015 B03H106D 1-Jun-2015

Distribution

Distributed nationwide across the United States.

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