TELEFLEX MEDICAL INC Recall 87346
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.
TELEFLEX MEDICAL INC Recall 87346 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1298-2021 |
| Event ID | 87346 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN. |
| Quantity | 520 units (US only) |
| Recall Reason | Teleflex is recalling this product due to a lack of assurance of sterility. |
| Device Classification | 20210331 |
| Device Code Info | Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE) |
| Center Classification Date | 20210324 |
| Recall Initiation Date | 20210212 |
| Recalling Firm | TELEFLEX MEDICAL INC |
| Initial Notification | Letter |
| Similar To |