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CTC-7

DAESUNG MAREF CO.,LTD. · Model CTC7100-RR-KUM · UDI-DI 08809802647206

ILO Prescription
10
510(k) clearances
984
Adverse events (3 deaths)
22
Recalls
125
Facilities

Description

Main Device 1ea, Reusable Knee Wrap 1ea, Reusable Universal Wrap(M) 1ea, Tubing 1ea, Assist Band 1ea, Recovery Bag 1ea [One Set Box]

Recalls

DateFirmReason
2026-03-19DJO, LLCDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19DJO, LLCDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19DJO, LLCDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19DJO, LLCDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
2021-11-22Gentherm Medical, LLCThis recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
2019-07-19Cincinnati Sub-Zero Products LLC, a Gentherm CompanyUpdated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
2017-11-07Stryker Medical Division of Stryker CorporationThe T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenanc
2015-01-07Cincinnati Sub-Zero Products IncSeals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
2013-09-17DeRoyal Industries IncThe unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it t
2013-09-17DeRoyal Industries IncThe unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it t

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.