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FOR IMMEDIATE RELEASE – March 12,
2010 – Limerick, PA – Teleflex Incorporated provided an update
today on the previously announced Arrow International, Inc.
voluntary recall of ALL lots of its Arrow custom
intravenous administration products (IV tubing sets and
accessories) and certain Arrow arterial embolectomy catheters
distributed prior to February 19, 2010.
Testing revealed pin holes in some of the pouches
in which the products are packaged, and it has been determined that
product sterility cannot be guaranteed. If product sterility has
been compromised, there is a potential for infection, which could
lead to serious injury or death. Arrow International has notified
the United States Food and Drug Administration (FDA) and other
health authorities of this recall.
Consumers who have:
- any Arrow product with a part number beginning with W
followed by five numeric digits (e.g., W12345);
- any Arrow product with a part number beginning with MPI
followed by five numeric digits (e.g., MPI-12345) which is an IV
tubing set or tubing set accessory;
- either of the following two part numbers IV-850001-AAMC
should STOP using and return the
items to Arrow International. Customers can find the entire
affected product list at www.teleflexmedical.com.
The affected product was distributed globally to
healthcare institutions and distributors.
No injuries have been reported to date however
significant under-reporting of adverse events may have
Arrow International initiated this field corrective
action in February 2010 and included notification to customers by
letter. Customers were directed to immediately quarantine affected
product and call the Arrow Custom IV Tubing hotline at 866-396-2111
to arrange for product return.
Customers with questions can contact the Arrow IV
Tubing customer service hotline at 866-396-2111 between the hours
of 8am and 8pm, ET, Monday through Friday.
Arrow International, Inc. is committed to providing
high quality, safe and effective products. Any adverse events
experienced with the use of this product, and/or quality problems
can also be reported to the FDA’s MedWatch Adverse Event Reporting
program by telephone at 1-800-FDA-1088 or online by visiting the
FDA website at http://www.fda.gov/Safety/MedWatch/default
and following the instructions for submitting the appropriate forms
electronically or by mail.
Neither the estimated costs nor the impact of this
recall are expected to be material to Teleflex’s 2010 financial
results. The voluntary recall and estimated costs were previously
reported in the company’s Form 10-K filed February 25, 2010.
Arrow International is a subsidiary of Teleflex Incorporated, a
diversified global company with a significant presence in medical
technology and niche businesses serving aerospace and commercial
markets. Teleflex Medical, the company’s largest business segment,
designs, manufactures and distributes medical devices for critical
care and surgical applications serving customers in more than 140
countries. The company is focused on medical device technology that
enables healthcare providers to improve outcomes, reduce infections
and improve patient and provider safety. Additional information
about Teleflex Incorporated can be obtained from the company’s
website at www.teleflex.com.