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Terminated

The Hemotherm 400CE 115v, containing power board p/n 39945

FDA Recall Z-0654-2017 · Posted 2016-11-22

Recalling FirmCincinnati Sub-Zero Products Inc
Recall StatusTerminated
Product CodeDWS
Date Initiated2016-11-07
Date Terminated2017-02-22
Product Quantity50

Reason for Recall

The device may not maintain water flow or temperature control.

Firm Action

Cincinnati Sub-Zero sent an Urgent Medical Device Correction letter date November 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm has notified all customers to discontinue use and contact CSZ. Upon receipt of the new board, immediately remove and discard the affected power board and replace it with the newly provided power board. The complete and return the customer response form. For further questions, please call (513) 772-8810

Root Cause

Material/Component Contamination

Distribution Pattern

US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc. · 2012-12-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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