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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 02, 2019
Create DateJune 21, 2019
Recall Status1 Terminated 3 on July 23, 2020
Recall NumberZ-1867-2019
Recall Event ID 82903
Product Classification Bath, incubators/water, all - Product Code JTQ
ProductFisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
Code Information Serial Numbers: 300247790
Recalling Firm/
Manufacturer		 Thermo Fisher Scientific (Asheville) LLC
401 Mill Creek Rd
Marietta OH 45750-4304
For Additional Information ContactSAME
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 2		Process control
ActionThermo 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 Commerce1 unit
DistributionCA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
Total Product Life CycleTPLC 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.
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