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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KOC
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