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

FDA device recall Z-1729-2014 · posted 2014-06-06 · Terminated

Recall details

Recalling firm

Cenorin, LLC

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.

Action taken

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 jwright@cenorin.com or call 800-426-1042, extension 224 for questions.

Root cause

Equipment maintenance

Status

Terminated

Product code

LDS

Quantity affected

25 HLD systems

Distribution

Distribution USA Nationwide

Date initiated

2014-04-24

Date posted

2014-06-06

Date terminated

2015-06-30

Location

Kent, WA