Recall Z-3033-2017 ยท JRJ Unit, Drying
Cenorin, LLC
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
| Date | Jun 7, 2017 |
| Status | Terminated |
| Reason | Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. |
| Root cause | Process control |
| Action | Cenorin initially contacted all domestic customers at the facility and distributor level via phone on June 7, 2017, which was followed by an Urgent Medical Device Recall letter dated July 20, 2017, to all affected customers. Cenorin sent initial notification to international distributors via email. Customers were asked to immediately examine their inventory for the affected product. If the product exhibits any symptoms of failure, immediately cease using it and contact Cenorin immediately at recall@cenorin.com or call Technical Support at 800-426-1042, ext 224. |
| Quantity | 43 units |
| Distribution | Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.