Class 2 Device Recall ACMI

• Date Initiated by Firm: April 30, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 13, 2005
• Recall Number: Z-0926-04
• Recall Event ID: 28975
• 510(K)Number: K980492
• Product Classification: Lithotriptor, Electro-Hydraulic - Product Code FFK
• Product: ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM
• Code Information: Lot numbers: 1122743E to 1269284B
• Recalling Firm/ Manufacturer: ACMI CORPORATION; 136 Turnpike Road; Southborough MA 01772
• For Additional Information Contact: Terence E. Sullivan; 508-804-2739
• Manufacturer Reason for Recall: Product sterility may be compromised due to the lack of package seal integrity
• FDA Determined Cause: Other
• Action: ACMI issued a recall letter dated 4/30/04 via Certified Mail. Users will be asked to return unused product. International Distributors were faxed letters notifying of them of the action.
• Quantity in Commerce: 541 boxes(3 probes/box)
• Distribution: Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey
• 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 = FFK