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U.S. Department of Health and Human Services

Class 2 Device Recall Haemonetics

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  Class 2 Device Recall Haemonetics see related information
Date Initiated by Firm July 28, 2006
Date Posted October 12, 2006
Recall Status1 Terminated 3 on October 24, 2006
Recall Number Z-0035-2007
Recall Event ID 36005
510(K)Number K052626  BK052626  
Product Classification suction device - Product Code BTA
Product SmartSuction Harmony Powered Suction Device
Model Number: HAR-E-115-US
Code Information Serial Numbers: 06F018, 06E133, 06A294-2, 06E132, 06A289 Foreign: 06C251, 06C252, 06C253, 06C254, 06C255, 06C242, 05D074-1, 06D075-1, 06F014-1, 06C248
Recalling Firm/
Manufacturer		 Haemonetics Corporation
400 Wood Rd
Eastern Maine Medical Center
Braintree MA 02184-2412
For Additional Information Contact John Sokolowski
781-848-7100
Manufacturer Reason
for Recall		 Faulty circuit board may short circuit and cause electric shock to operator
FDA Determined
Cause 2		 Other
Action Haemonetics issued recall leters on July 28, 2006 via Certified Mail, Return Receipt. Users are requested to return unit for repair or replacement.
Quantity in Commerce 15 units
Distribution AZ, CT, GA, NE, MS Austria, France, 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.
510(K) Database 510(K)s with Product Code = BTA and Original Applicant = HAEMONETICS CORP.
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