Teleflex Incorporated has issued an update on a previous recall of all lots of Arrow International, Inc. custom intravenous administration products (IV tubing sets and accessories) and some Arrow arterial embolectomy catheters. According to the Food and Drug Administration (FDA), testing has revealed pinholes in some of the pouches in which the products are packaged. It has been determined that these products do not meet sterility standards, which poses a potential risk for infection that could lead to serious injury or death.
The recall covers the IV tubing sets, accessories and aterial embolectomy catheters distributed worldwide prior to February 19, 2010, and includes any Arrow product with a part number beginning with W followed by five numeric digits; any Arrow product with a part number beginning with MPI followed by five numeric digits, 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.
Customers with these products should stop using them and return them to Arrow International immediately. A full list of recalled products can be found at www.TeleFlexMedical.com. Customers with questions should call the Arrow Custom IV Tubing hotline at 866-396-2111 between 8 a.m. and 8 p.m. ET, Monday through Friday.
To date, no injuries have been reported, however the agency is concerned that significant under-reporting of adverse events may have occurred. Any adverse events with this or any other medical product should be reported to the FDA MedWatch Adverse Events Reporting program at www.FDA.gov/MedWatch.