Z-2288-2018Class II

HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V &...

Name: Z-2288-2018 HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V &...
Creator: Cenorin, LLC
Published: 2018-04-09
License: https://open.fda.gov/license/

Cenorin, LLC / initiated 2018-04-09 / Terminated / root cause: manufacturing process

FDA source

Cenorin, LLC began a recall of HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and... on 2018-04-09. FDA classified it as Class II and gives the reason as "There is a supplier quality issue with the terminal blocks which may cause 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-2288-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-09
Posted: 2018-06-26
Terminated: 2019-09-13
Recalling firm: Cenorin, LLC
Product: HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
Product code: LDS Device, Pasteurization, Hot Water
Reason for recall: There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On April 9, 2018, Cenorin telephoned customers and then followed-up with a formal letter titled URGENT MEDICAL DEVICE RECALL via email. To mitigate this quality issue, Cenorin has a Corrective Kit available to replace the existing terminal blocks in the Washer/Pasteurizer as the long-term solution. In the meantime, here is how you can help with the recall process: 1. Please immediately examine your inventory for the recalled Washer/Pasteurizers listed and quarantine them to prevent further distribution. In addition, if you have further distributed this product, please notify your customers immediately using the enclosed notice. 2. If the Washer/Pasteurizers does not exhibit any of the symptoms of failure as noted, continue to use the Washer/Pasteurizers as normal until the service can be completed. If the Washer/Pasteurizers exhibit any of the symptoms of failure, immediately cease its use and contact Cenorin immediately at [email protected] or call Technical Support at 800-426-1042 ext. 224. 3. Complete the Recall Acknowledgement & Response Form and return to Cenorin as noted on form via email to [email protected] within 5 business days. Response is required. Customers with questions, please email Cenorin at [email protected] or call 253-395-2400 or toll-free 800-426-1042, extension 236 during the hours of business Monday through Friday, 7:30AM to 4:30PM, Pacific Standard Time.
Quantity in commerce: 14 units
Distribution: Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan
Product codes and lots: Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2288-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2288-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-26

Product code LDS

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)