Z-1298-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- February 12, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 520 units (US only)
Product Description
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.
Reason for Recall
Teleflex is recalling this product due to a lack of assurance of sterility.
Distribution Pattern
US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
Code Information
Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE)