Z-3034-2017Class II

ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010...

Name: Z-3034-2017 ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010...
Creator: Cenorin, LLC
Published: 2017-06-07
License: https://open.fda.gov/license/

Cenorin, LLC / initiated 2017-06-07 / Terminated / root cause: manufacturing process

FDA source

Cenorin, LLC began a recall of ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices on 2017-06-07. FDA classified it as Class II and gives the reason as "Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3034-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Posted: 2017-08-14
Terminated: 2018-05-02
Recalling firm: Cenorin, LLC
Product: ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
Product code: JRJ Unit, Drying
Reason for recall: Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Root cause tag: manufacturing process
FDA 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 [email protected] or call Technical Support at 800-426-1042, ext 224.
Quantity in commerce: 18 units
Distribution: Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
Product codes and lots: (a) Serial Numbers: 191601, 191602, 191604, 191605, 19161, 191611, 191612, 191613, 191614, 191615, 191616 (b) Serial numbers: 101505, 101506, 101603, 101606, 101607, 101608, 101609

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3034-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3032-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-14
Z-3033-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-14
Z-3034-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-14

Product code JRJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)