<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported) November 24, 1998
---------------------------
SABRATEK CORPORATION
- --------------------------------------------------------------------------------
(Exact Name of Registrant as Specified in Its Charter)
Delaware 1-11831 36-3700639
- --------------------------------------------------------------------------------
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification No.)
8111 North St. Louis, Skokie, Illinois 60076
- --------------------------------------------------------------------------------
(Address of Principal Executive Offices) (Zip Code)
(847) 720-2400
- --------------------------------------------------------------------------------
(Registrant's Telephone Number, Including Area Code)
Not Applicable
- --------------------------------------------------------------------------------
(Former Name or Former Address, if Changed Since Last Report)
<PAGE> 2
ITEM 5: Other Events
Sabratek Corporation ("Sabratek" or the "Company") announced that it
has suspended distribution of its Rocap flush product line. The suspension was a
result of discussions and meetings with the Food and Drug Administration (the
"FDA") regarding the status of Rocap's 510k submission which was filed with the
FDA in May, 1997. The halt in shipping is not the result of any quality, safety
or effectiveness problems with the product. Sabratek has agreed with the FDA to
resubmit 510k's for its Rocap flush products. Sabratek is taking actions to
focus all necessary resources on complying with 510(k) requirements as soon as
possible. Among other actions, as previously announced, Sabratek has placed new
management in charge of Rocap's operations and regulatory affairs. Sabratek
anticipates filing new 510k's within the next few weeks. It is uncertain as to
when Sabratek will be able to resume shipments.
It is uncertain how long this suspension will last. The Company
currently anticipates that the suspension will negatively impact financial
results of the fourth quarter, 1998 by $5-6 million in sales and $2-2.5 million
in pretax income, which is a material short fall to consensus analyst estimates
for the fourth quarter. Sabratek stated that while it hoped the FDA will make a
determination that Sabratek's 510k responses are adequate and allow it to resume
distribution during the fourth quarter, the Company could give no assurance that
this will occur.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: November 25, 1998 By: /s/ Stephen L. Holden
-------------------- --------------------------------
President
-2-
