Recall Z-1867-2019 ยท JTQ Bath, Incubators/Water, All
Thermo Fisher Scientific (Asheville) LLC
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
| Date | Apr 2, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Thermo Fisher issued on 4/02/19 via Email notification with attachments to distributors (domestic and foreign) the Urgent Medical Recall Notification Letter with customer response sheet. Recall is to the user level.On May 23, 2019 email followed by a formal written, "Urgent Medical Device Recall Notification Letter" with customer response sheet were sent via US mail to domestic customers. Letters address health risk and action to take: customer service team is prepared to send you a replacement immediately and the necessary materials and instructions for the return of the bath you received i |
| Quantity | 1 unit |
| Distribution | CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.