The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

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