Date Initiated by Firm |
April 30, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on June 13, 2005 |
Recall Number |
Z-0925-04 |
Recall Event ID |
28975 |
510(K)Number |
K980492
|
Product Classification |
Lithotriptor, Electro-Hydraulic - Product Code FFK
|
Product |
ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM |
Code Information |
Lot Numbers: 1122753E to 1283804C |
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 |
1479 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 and Original Applicant = CIRCON ACMI
|