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Terminated

Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

FDA Recall Z-0761-2019 · Posted None

Recalling FirmStihler Electronic Gmbh
Recall StatusTerminated
Product CodeKOC
Date Initiated2018-09-06
Date Terminated2020-05-13
Product Quantity247 units

Reason for Recall

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

Firm Action

STIHLER ELECTRONIC GMBH notified distributors by Registered mail/email and to Head of Biomedical on 09/06/18 identifying the problem, health risk and action to be taken: identify the Heating Profiles according to the serial numbers specified. These profiles must be replaced based on your accurate reply. Complete Inventory must be accounted for. For your reply use attached "Return Form" to Stihler Electronic GmbH. Send the filled return form via e-mail to nicola. vosseler@sti hlerelectronic. de. 3. You will receive the replacement Heating Profiles from our distributor Futuremed America Inc., 15700 Devonshire Street, Granada Hills, 91344 California, US.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082758PRISMAFLO IIStihler Electronic GmbH · 2008-12-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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