Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0160-2014 — Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional

U.S. FDA — Device Enforcement · United States · 2013-09-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0160-2014
Date of alert: 2013-09-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smiths Medical ASD, Inc.
Product category: device
Product type: Devices

Reported risk: Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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