Class 2 Device Recall Haemonetics

• Date Initiated by Firm: July 28, 2006
• Date Posted: October 12, 2006
• Recall Status: Terminated on October 24, 2006
• Recall Number: Z-0035-2007
• Recall Event ID: 36005
• 510(K)Number: K052626
• 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: 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