Legal news for product liability attorneys – Teleflex and the FDA announce voluntary recall of intravenous administration products under brand name Arrow International
Testing finds pinholes in pouches containing certain Arrow brand products, sterility compromised.
Limerick, PA – On Friday, March 12, 2010, Teleflex Incorporated provided an update on the previously announced Arrow International, Inc. voluntary recall of the custom intravenous administration products and embolectomy catheters, as reported by the FDA. Teleflex states that testing has revealed pinholes in some of the pouches in which the products are packaged. These holes compromise the sterility of the product, which can lead to potential infections, serious injury and death. Arrow International has notified the United States Food and Drug Administration (FDA) www.fda.gov of this recall. The product was distributed globally to health care institutions and distributors.
The recall specifies certain serial numbers for products that have been compromised. The list is as follows:
- 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 accessory
- Any product containing serial codes of IV-85001-AAMC and IV-85020-UW
Any consumer using one or more of these products should stop using the tool immediately and return the item/s to Arrow International.
No injuries were reported to authorities, although significant under-reporting may have occurred. This corrective action was initiated in February 2010, which included letter of notification to customers.
Customers with questions can contact Arrow IV Tubing customer service hotline at 866-396-2111, between the hours of 8:00 a.m. and 8:00 p.m. ET, Monday through Friday. Any quality problems or adverse effects can be reported to the FDA’s MedWatch Adverse Event Reporting program at 1-800-FDA-1088, or via the website http://www.fda.gov/Safety/MedWatch/default.
Legal News Reporter: Tara Monks – Legal news for product liability attorneys.