Recall -- Firm Press Release
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Teleflex Incorporated Announces Worldwide Voluntary Recall of Arrow Select IV Tubing Sets, Accessories, and Certain Embolectomy Catheters
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 and IV-85020-UW;
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 occurred.
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.