FDA Medical Device Recalls (openFDA)
Stihler Electronic Gmbh: 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.
- Recall number
- Z-0759-2019
- Recalling firm
- Stihler Electronic Gmbh
- 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.
- Status
- Terminated
- Initiated
- 2018-09-06
- Posted
- not on file
- Terminated
- 2020-05-13
- Reason
- 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
- Root cause
- Device Design
- 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.
- Quantity
- 821
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
- Lot, serial or model codes
- Serial Numbers: E22000 to E23999
- 510(k) numbers
- ["K082758"]
- PMA numbers
- not on file
- Product code
- KOC
- Firm FEI
- 3001733054
- Firm city
- Stuttgart
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28