FDA Recall Terminated

Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20

Recall: Z-1869-2019 · Initiated April 2, 2019

Recall

Recall Number
Z-1869-2019
Event Number
82903
Firm
Thermo Fisher Scientific (Asheville) LLC
FEI Number
1523845
Product Code
JTQ
Status
Terminated
Root Cause
Process control
Initiated
April 2, 2019
Terminated
July 23, 2020
Address
401 Mill Creek Rd, Marietta, OH, 45750-4304

Description

Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20

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.

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 initially to the factory. Please call representatives with your original purchase order, company name, and contact information at 866-984-3766 or email the included Recall Customer Response Form.

Distribution

CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia

Quantity

4 units