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

Recall Z-2163-2014 — Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal

U.S. FDA — Device Enforcement · United States · 2014-07-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2163-2014
Date of alert: 2014-07-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ICU Medical, Inc.
Product category: device
Product type: Devices

Reported risk: ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

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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