Recall Z-1298-2021 ยท GBX Catheter, Irrigation
TELEFLEX MEDICAL INC
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 lacera
| Date | Feb 12, 2021 |
| Status | Terminated |
| Reason | Teleflex is recalling this product due to a lack of assurance of sterility. |
| Root cause | Under Investigation by firm |
| Action | The affected customer is instructed to take the following actions: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. |
| Quantity | 520 units (US only) |
| Distribution | US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.