FDAFDA · Food and drugs·Recall number Z-3033-2017
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
Published August 23, 2017 · Recall initiated: June 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Cenorin, LLC
- Distributor
- Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
- Lot
- (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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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