FDA Device recall Z-3034-2017
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009
- FDA Device
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009 by Cenorin, citing dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3034-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-07 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cenorin |
| Distribution | US |
Product
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
Reason
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Identifiers
| code_info | (a) Serial Numbers: 191601, 191602, 191604, 191605, 19161, 191611, 191612, 191613, 191614, 191615, 191616 (b) Seri…(a) Serial Numbers: 191601, 191602, 191604, 191605, 19161, 191611, 191612, 191613, 191614, 191615, 191616 (b) Serial numbers: 101505, 101506, 101603, 101606, 101607, 101608, 101609 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3034-2017%22
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