PLEUR-EVAC Thoracic Catheters recalled over laceration hazard

Recall date

February 12, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

TELEFLEX MEDICAL INC recalls PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use dev…

Recall number

Z-1298-2021

FDA classification

Class II

Brand / firm

TELEFLEX MEDICAL INC

Sold / distributed

US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.

Why it was recalled

Teleflex is recalling this product due to a lack of assurance of sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar configurations in a variety of sizes. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.