Teleflex handed class I notice over IV recall
This article was originally published in Clinica
Executive Summary
Teleflex’s recall of its custom intravenous (IV) administration products has been given a class I notification by the FDA – the most serious type of recall notice. The faulty products include IV tubing sets and accessories manufactured by the firm’s Arrow International subsidiary from 2000 through 2009 and distributed prior to 19 February 2010. Teleflex (Limerick, Pennsylvania) discovered pin holes or punctures in the products’ packaging that could cause “blood-borne or other types of infections, which could result in serious injury or death”. The tubing sets are used to transfer fluids from a container to a patient’s blood vessel system.