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Terminated

Hemotherm CE, model 400CE, Heater-Cooling Device

FDA Recall Z-1825-2017 · Posted None

Recalling FirmCincinnati Sub-Zero Products Inc
Recall StatusTerminated
Product CodeDWC
Date Initiated2017-03-09
Date Terminated2017-12-18
Product Quantity390 devices

Reason for Recall

Improperly rated fuses were used in the manufacture of the device.

Firm Action

Letters were sent to customers and distributors instructing them to immediately cease use and/or further distribution of affected product, remove and discard the affected fuses and replace with the new fuses provided by CSZ, and complete and return the Field Action Response Form.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution. The recalled product was distributed to the following states: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The recalled product was distributed to the following countries: Mexico, Taiwan. There are no Canada accounts for this recall. There is one (1) Mexico account for this recall: Koolfer S.A. DE C.V., San Isidro 168, Col. Pedregal De Santa Ursula Coapa, Del. Coyoacan, CP. Mexico D. F. 04600. There is one (1) government account for this recall: WRNMMC -PAA, 8965 Brown Dr, Bethesda, MD 20889.

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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