HLD System recall
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Why was HLD System recalled?
The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.
- Product
- HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
- Recalling firm
- Cenorin, LLC
- Quantity
- 25 HLD systems
- Distribution
- Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
- Recall date
- July 16, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)