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U.S. Department of Health and Human Services

Class 2 Device Recall HLD SYSTEM 540

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  Class 2 Device Recall HLD SYSTEM 540 see related information
Date Initiated by Firm June 07, 2010
Date Posted October 12, 2010
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-0037-2011
Recall Event ID 55802
Product Classification Device, pasteurization, hot water - Product Code LDS
Product HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater.

Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com".

Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
Code Information Serial numbers for Model 540 without Kits/Parts:  549204, 540702, 540716, 540717, 540718, 540719, 540720, 540721, 540722, 540728, 540811, 540812, 540813, 541001, 541005, and 541006.  The firm uses a serial number as broken down in the following format AABBCC:  AA digits represent the Model Number;  BB digits represent the last two digit of the manufacturing year;  CC digits represent the unique number of the unit.  
Recalling Firm/
Manufacturer		 Cenorin
6324 S 199th Pl Ste 107
Kent WA 98032
For Additional Information Contact Jenette Bennett
253-395-2400 Ext. 237
Manufacturer Reason
for Recall		 The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized
FDA Determined
Cause 2		 Component design/selection
Action On June 7, 2010, firm, CENORIN, sent "URGENT: MEDICAL DEVICE RECALL" Initial Notification letter with Recall Response Form, Series 500 Water Level Check Instructions, and the Water Level Switch Upgrade Kit Instruction (service kit P/N # 082395-00) to their consignees. The firm also sent these documents in Spanish language to their foreign consignees. The letter describes the recall product as HLD Systems Medical Device Cleaning and High Level Disinfection Series 500 Washer/Pasteurizer-Model 540, Model 540HT and Model 520. Customers are advised to call the Customer Service at 1-800-426-1402 or e-mail the firm. The Initial Notification letter instructs consignees to conduct and quarantine the recall products and notify their sub-accounts (customers) if products have been further distributed. While waiting for a replacement kit, the consignees are asked to follow the Series 500 Water Level Check Instructions to perform a test to ensure the water tank is completely filled up the expected water level. The firm also advised the consignees to add a cautionary label on the product to avoid any sharp or bump impact that may create any externally induced vibration noise to the device. The firm is developing a replacement kit that should be ready to send out to their consignees by June 30, 2010. A response card would be also sent out with a new kit, and it is used to verify that the kit has been successfully implemented. If you have any questions, please email jbennett@cenorin.com or call 253-395-2400 or toll free: 1-800-426-1042.
Quantity in Commerce 16 units
Distribution Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
Total Product Life Cycle TPLC Device Report
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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