Lintronics -- cannot distribute products in U.S., but what happened to overseas sales?
Now I suspect that I (finally) know the reason why the company did not go public with an initial public offering, but rather when the route of purchasing a corporate "shell".
CLASS I RECALLS AND FIELD CORRECTIONS: DEVICES -- Lintronics Technologies, Inc.
08/10/94
FDA Enforcement Report Food & Drug Administration No. 94-3
Copyright 1994 Public Domain
PRODUCT: Breast Transilluminator, Lintroscan Model 200G used for the detection of changes in the breast. Recall Z-1184-4.
CODE: Serial numbers: 080792-02, 082492-03, 082492-04, 01092-05, 01092-06, 01092-07.
MANUFACTURER: Lintronics Technologies, Inc., Tampa, Florida.
RECALLED BY: Manufacturer, by telephone mid November 1993. Firm-initiated recall complete.
DISTRIBUTION: Illinois, Ohio, Georgia, Florida, Virginia.
QUANTITY: 6 units.
REASON: Product labeling fails to bear adequate directions for use. FDA has concluded that transillumination for the examination of the breast is not clinically effective for the diagnosis or detection of breast cancer or other breast abnormalities or conditions.
A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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