Teleflex Incorporated has issued a worldwide 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.
Teleflex’s Arrow International subsidiary initiated this field corrective action in February 2010 and included notification to customers by letter. Customers were directed to immediately quarantine <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">affected devices and call the Arrow Custom IV Tubing hotline at 866-396-2111 to arrange for product return.
No injuries related to this defect have been reported to date, however the recall notice cautions that significant under-reporting of adverse events may have occurred.
According to the recall notice, 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:
â€¢ any Arrow product with a part number beginning with W followed by five numeric digits (e.g., W12345);
â€¢ 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;
â€¢ 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.
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.