Recall Z-0761-2019— Stihler Electronic Gmbh

Name: FDA recall Z-0761-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-06

Class II · Terminated

Class II FDA medical device recall by Stihler Electronic Gmbh, initiated 2018-09-06, terminated 2020-05-13. It names one FDA 510(k) clearance: K082758. 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.. 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.

Recalling firm: Stihler Electronic Gmbh
Classification: Class II
Status: Terminated
Initiated: 2018-09-06
Terminated: 2020-05-13
Firm location: Stuttgart, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K082758 — PRISMAFLO IIStihler Electronic GmbH·cleared 2008-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.