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U.S. Department of Health and Human Services

Class 2 Device Recall Steris Ultrasonic instrument cleaner

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 Class 2 Device Recall Steris Ultrasonic instrument cleanersee related information
Date Initiated by FirmJune 22, 2006
Date PostedAugust 25, 2006
Recall Status1 Terminated 3 on January 08, 2007
Recall NumberZ-1407-06
Recall Event ID 35737
Product Classification Ultrasonic instrument cleaner - Product Code FLG
ProductSteris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS
Code Information All units bearing serial numbers 0432000018 to 0403105051.
Recalling Firm/
Manufacturer		 Steris Corporation
2720 Gunter Park Dr E
Montgomery AL 36109-1410
For Additional Information ContactKenneth P. Finch
334-274-5183
Manufacturer Reason
for Recall		Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.
FDA Determined
Cause 2		Other
ActionThe firm sent out a certified letter to all affected consignees alerting them to problems with the device on 6/22/06.
Quantity in Commerce322 units
DistributionWorldwide USA and countries of Japan, Canada, Hong Kong, Korea, Lebanon, Qatar, Poland, Russia, Saudi Arabia, Singapore, Taiwan, Germany, Northern Mariana Islands, and Malaysia.
Total Product Life CycleTPLC 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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