UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): December 3, 2004
--------------------------
ARROW INTERNATIONAL, INC.
-------------------------
(Exact Name of Registrant as Specified in its Charter)
Pennsylvania 0-20212 23-1969991
- ---------------------------- ------------ --------------
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification No.)
2400 Bernville Road, Reading, Pennsylvania 19605
- ---------------------------------------------- ------------------
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (610) 378-0131
--------------
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
ARROW INTERNATIONAL, INC.
Item 8.01. Other Events.
On December 3, 2004, the Company announced that, after consulting with the Food
and Drug Administration, it is voluntarily initiating a nationwide recall of all
of its NeoPICC(R) 1.9 FR Peripherally Inserted Central Catheters (the "NeoPICC
Catheters"). To date, the Company has received six reports of adverse events,
including one death, during which the NeoPICC Catheter was utilized. All of
these events have been reported to involve possible vessel erosion following
placement of the catheter and administration of fluids. Five of these events
originated from one hospital, while the sixth event occurred at a second
hospital. The Company is currently investigating the potential cause of these
events and whether they are a direct result of the NeoPICC Catheter or due to
other factors that occurred during the period of care.
The NeoPICC Catheter is part of the Company's NeoCare product line of catheters
and related procedure kits for neonatal intensive care that it acquired from
Klein Baker Medical, Inc. in March 2003. The Company sold a total of 63,461 of
the NeoPICC Catheters in fiscal year 2004, amounting to $2,681,039, which
represented approximately 35% of its total sales of all NeoCare products during
the fiscal year. Inventories of NeoPicc Catheters in the Company's warehouses at
November 30, 2004 amounted to $171,704. The Company anticipates that it will
send recall notices to approximately 500 hospitals and 13 dealers, but is unable
at the present time to estimate the number of NeoPICC Catheters that will
eventually be returned by customers in response to this voluntary recall.
A copy of the Company's press release dated December 3, 2004 announcing this
recall is attached to this report as Exhibit 99.1 and is incorporated herein by
reference.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits
Exhibit Number Description
- -------------- -----------
99.1 Press release dated December 3, 2004 issued by the Company
regarding the voluntary nationwide recall of all its
NeoPICC(R) 1.9 FR Peripherally Inserted Central Catheters.
ARROW INTERNATIONAL, INC.
SIGNATURE
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.
ARROW INTERNATIONAL, INC.
Date: December 8, 2004 By: /s/ Frederick J. Hirt
-------------------------------------
Frederick J. Hirt
Chief Financial Officer and
Senior Vice President-Finance
(Principal Financial Officer and
Chief Accounting Officer)
EXHIBIT INDEX
EXHIBIT DESCRIPTION
NUMBER OF EXHIBIT METHOD OF FILING
- ------ ---------- ----------------
99.1 Press Release dated December 3, 2004, Furnished herewith.
issued by the Company regarding the
voluntary nationwide recall of all its
NeoPICC(R) 1.9 FR Peripherally Inserted
Central Catheters.