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U.S. Department of Health and Human Services

Class 2 Device Recall HLD Systems

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 Class 2 Recall
HLD Systems
see related information
Date Posted June 06, 2014
Recall Status1 Open
Recall Number Z-1729-2014
Recall Event ID 68237
Product Classification Device, Pasteurization, Hot Water - Product Code LDS
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.
Code Information 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.
Recalling Firm/
Manufacturer
Cenorin, LLC
6324 S 199th Pl Ste 107
Kent, Washington 98032-2135
For Additional Information Contact Jenette Bennett
253-395-2400 Ext. 236
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 jwright@cenorin.com or call 800-426-1042, extension 224 for questions.
Quantity in Commerce 25 HLD systems
Distribution Worldide Distribution - USA Nationwiide - products were distributed to 19 hospitals throughout the USA and to 3 hospitals outside the US.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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