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TELEFLEX MEDICAL INC recalls PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use devi
Recalled March 31, 2021 · FDA recall Z-1298-2021 · TELEFLEX MEDICAL
Hazard
Teleflex is recalling this product due to a lack of assurance of sterility. · FDA Class II
Units
520 units (US only)
Sold at
US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Description
Teleflex is recalling this product due to a lack of assurance of sterility.
Product
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.
Manufacturer(s)
TELEFLEX MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →