Recall Z-1866-2019— Thermo Fisher Scientific (Asheville) LLC
Class II · Terminated
Class II FDA medical device recall by Thermo Fisher Scientific (Asheville) LLC, initiated 2019-04-02, terminated 2020-07-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10. Reason: Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user..
- Recalling firm
- Thermo Fisher Scientific (Asheville) LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-02
- Terminated
- 2020-07-23
- Firm location
- Marietta, OH, United States
Product description
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10
Reason for recall
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Data sourced from openFDA. This site is unofficial and independent of the FDA.