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U.S. Department of Health and Human Services

Class 2 Device Recall Heating Profile PRISMAFLO II S blood return warmer

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  Class 2 Device Recall Heating Profile PRISMAFLO II S blood return warmer see related information
Date Initiated by Firm September 06, 2018
Create Date January 23, 2019
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-0759-2019
Recall Event ID 81755
510(K)Number K082758  
Product Classification Accessories, blood circuit, hemodialysis - Product Code KOC
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.
Code Information Serial Numbers: E22000 to E23999
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
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 821
Distribution Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KOC and Original Applicant = STIHLER ELECTRONIC GMBH
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