Recall Z-0759-2019

Stihler Electronic Gmbh · initiated September 6, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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.

Codes / lots: Serial Numbers: E22000 to E23999

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

FDA-determined cause: Device Design

Action taken

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.

Details

Recall number
Z-0759-2019
Initiated
September 6, 2018
Terminated
May 13, 2020
Product code
KOC – Accessories, Blood Circuit, Hemodialysis
Quantity
821
Distribution
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Recalling firm
Stihler Electronic Gmbh, Stuttgart

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0760-2019 Class IIHeating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31…PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a… 09/06/2018Terminated
Z-0761-2019 Class IIHeating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618…PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a… 09/06/2018Terminated