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

3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exi — recall Z-0598-2018

U.S. FDA — Device Enforcement · United States · 2018-01-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0598-2018
Date of alert: 2018-01-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: 3M Company - Health Care Business
Product category: device
Product type: Devices

Reported risk: Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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