Device 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.
Z-1298-2021
Product summary
- Event
- Event 87346
- Status
- Terminated
- Classification
- Class II
- Quantity
- 520 units (US only)
- Official record key
device-enforcement:Z-1298-2021
Official wording
Reason: Teleflex is recalling this product due to a lack of assurance of sterility.
Code information: Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE)
Distribution pattern: US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Derived failure modes
-
Sterility assurance
lack of assurance of sterility