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

Recall Z-2417-2015 — Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring

U.S. FDA — Device Enforcement · United States · 2015-07-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2417-2015
Date of alert: 2015-07-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Radiometer America Inc
Product category: device
Product type: Devices

Reported risk: When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.

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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