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U.S. Department of Health and Human Services

Class 2 Device Recall Routine Service Kits or Parts for HLD SYSTEM

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  Class 2 Device Recall Routine Service Kits or Parts for HLD SYSTEM 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-0039-2011
Recall Event ID 55802
Product Classification Device, pasteurization, hot water - Product Code LDS
Product The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS ***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com".

Service Kit P/N: 082395-00 Series 500 Water Level Switch Upgrade Kit: The purpose of this service kit was to provide replacement parts for customers who had HLD Systems that were manufactured prior to 3/22/07.These systems were manufactured with old, old switches that have been obsolete and discontinued. Part P/N: 030500-00 Switch, Liquid Level: This part was sold by itself to a foreign consignee in Japan for inventory purposes only for regularly scheduled maintenance of a device or replacement of parts at the end of their normal life expectancy.
Code Information The routine service Kit # 082395-00 or Part # 030500-00. Kits do not contain serial number.  Four kits were distributed one each for Model 520 with Serial numbers 529701 and 520502 and for Model 540 with Serial numbers 549204 and 540607.  The remaining 18 kits were shipped to consignees who purchased several kits or parts for inventory or service purpose, and they are not known for what specific device.
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 24 kits
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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