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

Recall Z-0573-2018 — Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

U.S. FDA — Device Enforcement · United States · 2017-06-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0573-2018
Date of alert: 2017-06-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: B. Braun Medical, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0061480990

Reported risk: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

Recall Z-0573-2018 — Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

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