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U.S. Department of Health and Human Services

Class 2 Device Recall ACMI

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 Class 2 Device Recall ACMIsee related information
Date Initiated by FirmApril 30, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 13, 2005
Recall NumberZ-0925-04
Recall Event ID 28975
510(K)NumberK980492 
Product Classification Lithotriptor, Electro-Hydraulic - Product Code FFK
ProductACMI 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 ContactTerence 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
ActionACMI 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 Commerce1479 boxes (3 probes/box)
DistributionNationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FFK
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