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

EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous — recall Z-3401-2018

U.S. FDA — Device Enforcement · United States · 2018-07-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3401-2018
Date of alert: 2018-07-20
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): 61603099

Reported risk: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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