Recall Z-0759-2019 ยท KOC Accessories, Blood Circuit, Hemodialysis
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.
| Date | Sep 6, 2018 |
| Status | Terminated |
| 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., |
| Quantity | 821 |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082758 | PRISMAFLO II Stihler Electronic GmbH, Dec 19, 2008 |