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

Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in a — recall Z-0271-2018

U.S. FDA — Device Enforcement · United States · 2017-10-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0271-2018
Date of alert: 2017-10-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: C.R. Bard, Inc.
Product category: device
Product type: Devices

Reported risk: Hydrogel peeling from the pads.

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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