Date Initiated by Firm | April 30, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on June 13, 2005 |
Recall Number | Z-0928-04 |
Recall Event ID |
28975 |
510(K)Number | K980492 |
Product Classification |
Lithotriptor, Electro-Hydraulic - Product Code FFK
|
Product | ACMI REF E-9F Electrohydraulic Lithotripsy Probe,
9 FR x 60CM |
Code Information |
Lot Numbers: 115823D to 1283724C |
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 2 | 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 | 951 boxes(6 probes/box) |
Distribution | Nationwide
Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = FFK
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