Sterility Issue at the Center of Teleflex Inc.'s Voluntary Recall
Teleflex Inc. (Limerick, PA) provided an update 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 before Feb. 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 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, such as W12345; any Arrow product with a part number beginning with MPI followed by five numeric digits, including MPI-12345, which is an IV tubing set or tubing set accessory; and either of the following two part numbers IV-850001-AAMC and IV-85020-UW; should stop using and return the items to Arrow International.
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/default1 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