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

Recall Z-0759-2019 — Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

U.S. FDA — Device Enforcement · Germany · 2018-09-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0759-2019
Date of alert
2018-09-06
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Stihler Electronic Gmbh
Product category
device
Product type
Devices
Reported risk: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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