Z-0761-2019Class II

Heating Profile PRISMAFLO II blood return warmer for Prismaflex

Name: Z-0761-2019 Heating Profile PRISMAFLO II blood return warmer for Prismaflex
Creator: Stihler Electronic Gmbh
Published: 2018-09-06
License: https://open.fda.gov/license/

Stihler Electronic GmbH / initiated 2018-09-06 / Terminated / root cause: design

FDA source

Stihler Electronic Gmbh began a recall of Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return... on 2018-09-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0761-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-06
Posted: 2019-01-23
Terminated: 2020-05-13
Recalling firm: Stihler Electronic GmbH
Product: 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.
Product code: KOC Accessories, Blood Circuit, Hemodialysis
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
Root cause tag: design
FDA 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 in commerce: 247 units
Distribution: Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Product codes and lots: Serial Numbers: UH07154 to UH07479

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0761-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0759-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-23
Z-0760-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-23
Z-0761-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-23

Product code KOC

K082758Class IIPrismaflo IIStihler Electronic GmbH / cleared 2008-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)