Teleflex has provided an update on the previously announced Arrow International's 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.
The recall has been done due to the pin holes observed 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 FDA and other health authorities of this recall.
Teleflex said that the consumers who have any Arrow product with a part number beginning with W followed by five numeric digits (W12345); any product with a part number beginning with MPI followed by five numeric digits (MPI-12345) which is an IV tubing set or tubing set accessory; either of the two part numbers like IV-850001-AAMC and IV-85020-UW, should STOP using and return the items to Arrow International.
The affected product has been distributed globally to healthcare institutions and distributors. No injuries have been reported to date however under-reporting of adverse events may have occurred. Arrow had initiated the field corrective action in February 2010 and included notification to customers by letter and the customers were directed to immediately quarantine affected product.