MURRAY HILL, N.J.--(BUSINESS WIRE)--Jan. 13, 2006--C. R. Bard,
Inc. (NYSE: BCR) today announced that it is voluntarily recalling its
Bard(R) Composix(R) Kugel(R) Mesh X-Large Patch intended for ventral
hernia repair. This recall does not affect any of the company's other
hernia repair products.
The company is initiating this recall due to reports that the
device's plastic coil ring, designed to aid in its deployment, may not
withstand the increased stress associated with certain surgical
placement techniques. The company has received 24 reports of broken
rings out of approximately 32,000 units sold since 2002, a rate of
The products affected by this recall were distributed to customers
worldwide. Bard has notified affected customers and the appropriate
regulatory agencies, including the U.S. Food and Drug Administration.
The three product codes involved generated sales of approximately
$11 million in 2005, before the effect of the recall.
The company expects to record a sales reduction and related
charges associated with the recall in the 2005 fourth quarter and
these adjustments will cause the company's results to be below
previously stated guidance for the quarter. The company remains
comfortable with its previously stated guidance for 2006 of constant
currency net sales growth of between 9 percent and 10 percent and
diluted earnings per share equivalent to a minimum of $3.42, excluding
the effect of FAS123R.
C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill,
N.J., is a leading multinational developer, manufacturer, and marketer
of innovative, life-enhancing medical technologies in the fields of
vascular, urology, oncology and surgical specialty products.
This press release may contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995,
which are based on management's current expectations, the accuracy of
which is necessarily subject to risks and uncertainties. These
statements are not historical in nature and use words such as
"anticipate", "estimate", "expect", "project", "intend", "forecast",
"plan", "believe", and other words of similar meaning in connection
with any discussion of future operating or financial performance. Many
factors may cause actual results to differ materially from anticipated
results including product developments, sales efforts, income tax
matters, the outcomes of contingencies such as legal proceedings, and
other economic, business, competitive and regulatory factors. The
company undertakes no obligation to update its forward-looking
statements. Please refer to our September 30, 2005 10-Q for more
detailed information about these and other factors that may cause
actual results to differ materially from those expressed or implied.
Net sales, excluding foreign exchange, ongoing net sales and net
income and diluted earnings per share (EPS) excluding certain items
are non-GAAP financial measures. The company analyzes net sales on a
constant currency and ongoing basis to better measure the
comparability of results between periods. Because changes in foreign
currency exchange rates have a non-operating impact on net sales, the
company believes that evaluating growth in net sales on a constant
currency basis provides an additional and meaningful assessment of net
sales. The company believes that comparing ongoing net sales between
periods provides an additional and meaningful analysis of comparable
operations. Net income and EPS excluding certain items are used by the
company to measure the comparability of results between periods.
Certain items such as investment gains and litigation outcomes may not
reflect underlying operating results, and other items such as the
FAS123R stock option expense may affect the comparability of results
between periods. As a result, the company believes the exclusion of
these and similar items provides an additional and meaningful
assessment of net income and EPS. The limitation of these non-GAAP
measures is that, by excluding certain items, they do not reflect
results on a standardized reporting basis. All non-GAAP financial
measures are intended to supplement the applicable GAAP disclosures
and should not be viewed as a replacement for GAAP results. For a
reconciliation of these non-GAAP measures to the most comparable GAAP
measures, please see the investor relations section of the company's
web site, www.crbard.com.
CONTACT: C. R. Bard, Inc.
Eric J. Shick, 908-277-8413
Holly P. Glass, 703-754-2848
SOURCE: C. R. Bard, Inc.