Medical device developer Teleflex Medical has issued a voluntary recall of the Arrow Select IV Tubing sets, accessories and certain lots of arterial embolectomy catheters after it discovered faults with the product's sterility.
The recall was issued after the company found pin holes in its packaging pouches that may have compromised product sterility and could increase the risk of infection in patients, potentially leading to injury or death.
According to Teleflex, currently no adverse events have been reported; however, the company believes that the under-reporting of events may have occurred.
The company suggests that healthcare professionals cease using the following recalled products distributed prior to Feb. 19:
- Arrow products beginning with W followed by five numeric digits (e.g., W12345);
- Arrow IV tubing sets or tubing set accessories starting with MPI followed by five number digits; and
- Products with part numbers: IV-850001-AAMC and IV-85020-UW.
A full list of the Arrow recalled products can be found here.
In February, Reading, Pa.-based Arrow, a subsidiary of Teleflex, sent notification letters of the recall to its customers.
The company has urged customers to call the Arrow IV tubing customer service hotline at 1-866-396-2111 with questions, and advised that all adverse events be reported to the FDA’s MedWatch Adverse Event Reporting program.