Class 2 Device Recall Fisher Scientific Isotemp General Purpose Water Bath

• Date Initiated by Firm: April 02, 2019
• Create Date: June 21, 2019
• Recall Status: Terminated on July 23, 2020
• Recall Number: Z-1865-2019
• Recall Event ID: 82903
• Product Classification: Bath, incubators/water, all - Product Code JTQ
• Product: Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
• Code Information: Serial Numbers: 30024679S 300246796 300246797 300246798 300246799 300247393 300247394 30024739S 300247396 3002477S8
• Recalling Firm/ Manufacturer: Thermo Fisher Scientific (Asheville) LLC; 401 Mill Creek Rd; Marietta OH 45750-4304
• For Additional Information Contact: SAME; 740-373-4763
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 10 units
• Distribution: CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.