FDA-Device2021-03-31Class II
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 per
TELEFLEX MEDICAL INC
Hazard
Teleflex is recalling this product due to a lack of assurance of sterility.
Sold states
US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Affected count
520 units (US only)
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1298-2021Don't want to check this manually?
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