Agency classClass IIOur severity:Severe FDA (Devices)·Z-3034-2017·Announced 2017-08-23

Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block

Cenorin, LLC is recalling 18 ThermaSure Series 1000 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a manufacturing defect causing the terminal block to overheat, char, and/or burn, which constitutes a significant injury or property-damage risk under the rubric for Severe recalls.

Plain-English summary

Cenorin, LLC is recalling 18 units of the ThermaSure Series 1000 Medical Device Dryer, specifically Models 1009 and 1010. The recall involves specific serial numbers for both models, which are listed in the official agency documentation.

The recall is due to a manufacturing issue that causes the terminal block to overheat, char, and/or burn. This defect can result in the dryer unit not heating properly. The affected units were distributed nationwide in the United States and internationally to Japan, Hong Kong, Brunei, and Israel.

Consumers and healthcare facilities should stop using the affected dryers and contact Cenorin, LLC for instructions on how to proceed with the recall.

The recalled product

Product: ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
Manufacturer: Cenorin, LLC
Category: Medical Device — Medical Device Dryer
Hazard: fire
burn-injury
Affected units: 18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

(a) Serial Numbers: 191601
191602
191604
191605
19161
191611
191612
191613
191614
191615
191616 (b) Serial numbers: 101505
101506
101603
101606
101607
101608
101609

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cenorin, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Cenorin, LLC

See all →

High
HLD Systems Washer Pasteurizer Recalled for Terminal Block Overheating
FDA (Devices) · 2018-07-04
High
Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block
FDA (Devices) · 2017-08-23
High
Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block
FDA (Devices) · 2017-08-23
High
Cenorin HLD System Model 610 Recalled for Temperature Sensor Defect
FDA (Devices) · 2014-07-16
Moderate
Cenorin HLD Systems Model 610 Washer Recalled for Cleaning Fluid Defect
FDA (Devices) · 2014-06-18

Same hazard · fire