Class 2 Device Recall Easy Go Vac

• Date Initiated by Firm: November 09, 2004
• Date Posted: December 15, 2004
• Recall Status: Terminated on June 12, 2007
• Recall Number: Z-0307-05
• Recall Event ID: 30500
• 510(K)Number: K971749
• Product Classification: Pump, Portable, Aspiration (Manual Or Powered) - Product Code BTA
• Product: Easy Go Vac Aspirator, Model PM65. Portable suction unit
• Code Information: Serial Numbers:008360 to 14360 Charger part number 503974 (Globtek Part # GTM21097CC-5015-1.3 Part No: GS-307-B)
• Recalling Firm/ Manufacturer: Precision Medical, Inc.; 300 Held Dr; Northampton PA 18067-1150
• For Additional Information Contact: Jim Parker; 610-262-6090 Ext. 228
• Manufacturer Reason for Recall: Battery charger can be overcharged and overheat
• FDA Determined Cause: Other
• Action: The recalling firm sent Recall letters via first class mail on 11/15/04 to their consignees. The recalling firm will replace the chargers free of charge.
• Quantity in Commerce: 6000 units
• Distribution: The product was shipped to medical supply companies and medical facilities nationwide. The product was also shipped to Saudi Arabia, Boliva, Hong Kong, Israel, Brazil, Phillipines, Poland, Canada, Ireland, New Zealand, France, United Kingdom, and Singapore.
• 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