Z-1729-2014Class II

HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water...

Name: Z-1729-2014 HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water...
Creator: Cenorin, LLC
Published: 2014-04-24
License: https://open.fda.gov/license/

Cenorin, LLC / initiated 2014-04-24 / Terminated / root cause: manufacturing process

FDA source

Cenorin, LLC began a recall of HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the... on 2014-04-24. FDA classified it as Class II and gives the reason as "Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving...". 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-1729-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-24
Posted: 2014-06-06
Terminated: 2015-06-30
Recalling firm: Cenorin, LLC
Product: HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F 2 F for 30 minutes.
Product code: LDS Device, Pasteurization, Hot Water
Reason for recall: Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Cenorin sent a letter on April 24, 2014 informing their customers of the potential failure of the pump. This letter also explains the customer's option of upgrading their entire HLD System to the new cleaning fluid delivery system or to continue purchasing a six month PM kit that has a replacement pump added. Customers are instructed to complete and return an enclosed response form within 15 days and to email Jamie Wright at [email protected] or call 800-426-1042, extension 224 for questions.
Quantity in commerce: 25 HLD systems
Distribution: Distribution USA Nationwide
Product codes and lots: 610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204. First two digits (61) refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits sequentially numbered as they receive orders.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1729-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1729-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-06

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)