TELEFLEX MEDICAL INC recalls PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The th
Recalled 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.
Hazard / Issue
Teleflex is recalling this product due to a lack of assurance of sterility.
Issued by
FDA
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