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U.S. Department of Health and Human Services

Class 2 Device Recall Heating Profile PRISMAFLO II blood return warmer

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 Class 2 Device Recall Heating Profile PRISMAFLO II blood return warmersee related information
Date Initiated by FirmSeptember 06, 2018
Create DateJanuary 23, 2019
Recall Status1 Terminated 3 on May 13, 2020
Recall NumberZ-0761-2019
Recall Event ID 81755
510(K)NumberK082758 
Product Classification Accessories, blood circuit, hemodialysis - Product Code KOC
ProductHeating 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.
Code Information Serial Numbers: UH07154 to UH07479
Recalling Firm/
Manufacturer		 Stihler Electronic Gmbh
Julius-Holder-Str. 36
Stuttgart Germany
Manufacturer 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 2		Device Design
ActionSTIHLER 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 Commerce247 units
DistributionWorldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KOC
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