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

Recall Z-1145-2017 — HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

U.S. FDA — Device Enforcement · United States · 2016-10-31 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1145-2017
Date of alert: 2016-10-31
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Smiths Medical ASD, Inc.
Product category: device
Product type: Devices

Reported risk: HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

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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