| Class 2 Device Recall HLD Systems | |
Date Initiated by Firm | April 24, 2014 |
Date Posted | June 06, 2014 |
Recall Status1 |
Terminated 3 on June 30, 2015 |
Recall Number | Z-1729-2014 |
Recall Event ID |
68237 |
Product Classification |
Device, pasteurization, hot water - Product Code LDS
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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 WA 98032-2135
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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 | 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 | Distribution USA Nationwide |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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