Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or

FDA device recall Z-0063-2019 · posted 2018-10-03 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products LLC, a Gentherm Company

Reason for recall

Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.

Action taken

On September 4, 2018, the firm, CSZ, issued an "Urgent Medical Device Correction" notices to customers overnight via courier service. Customers were advised to take the following actions: - Immediately examine your inventory and quarantine product subject to the field action. - If you choose to use the product prior to the correction, please consider having a backup device available. - In addition, if you have further distributed this product, please identify your customers and notify them at once of this medical device correction. Your notification to your customers may be enhanced by including a copy of the Urgent Medical Device Correction letter. - Contact CSZ Technical Support (1-888-437-5608) for a replacement kit: Reference FA2017-015 for the Hemotherm control panel kit or you may contact CSZ Technical Support to request replacement by a CSZ representative. - Once the replacement kit is received follow Hemotherm Control Panel Replacement Instructions provided in the kit. - Complete and return the response form provided to acknowledge receipt of the notification and to inform CSZ that customers have performed the requested actions via fax to (513) 772-9119 or via email to FA2017-015@genthermcsz.com. If you have any questions, call Kathy DeSmidt @ 513-772-8810.

Root cause

Device Design

Status

Terminated

Product code

DWC

Quantity affected

270 units

Distribution

US Nationwide Distribution

Date initiated

2018-09-04

Date posted

2018-10-03

Date terminated

2019-05-23

Location

Cincinnati, OH

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