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

Recall Z-1680-2015 — D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory para

U.S. FDA — Device Enforcement · United States · 2015-04-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1680-2015
Date of alert: 2015-04-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare
Product category: device
Product type: Devices

Reported risk: A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. This water trap occlusion could cause a loss of respiratory airway gas monitoring.

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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