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Recall Observatory FDA recall evidence

Device product

ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices

Z-3033-2017

June 07, 2017

Class II

Product summary

Firm
Cenorin, LLC
Event
Event 77637
Status
Terminated
Classification
Class II
Quantity
43 units
Official record key
device-enforcement:Z-3033-2017

Official wording

Reason: Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

Code information: (a) Serial Numbers: 331517, 331518, 331523, 331524, 331525, 331526, 331527, 331528, 331529, 331530, 331601, 331608, 331609, 331612, 331615, 331616, 331621, 331622, 331623, 331624, 331625, 331626, 331627 (b) Serial numbers: 341506, 341507, 341516, 341520, 341521, 341522, 341602, 341603, 341604, 341605, 341606, 341607, 341610, 341611, 341613, 341614, 341617, 341618, 341619, 341620

Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.