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

Recall Z-0091-2015 — Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent,

U.S. FDA — Device Enforcement · United States · 2014-09-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0091-2015
Date of alert: 2014-09-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Codman & Shurtleff, Inc.
Product category: device
Product type: Devices

Reported risk: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)

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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