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

Recall Z-1311-2019 — MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid spac

U.S. FDA — Device Enforcement · United States · 2019-04-08 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1311-2019
Date of alert: 2019-04-08
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Integra LifeSciences Corp.
Product category: device
Product type: Devices

Reported risk: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

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.

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