Class II — TELEFLEX MEDICAL INC
| Recalling firm | Teleflex |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Teleflex is recalling this product due to a lack of assurance of sterility. |
| 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 obst… |
| Quantity | 520 units (US only) |
| Distribution | US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN. |
| Initiated | 2021-02-12 |
| Classified | 2021-03-24 |
| Terminated | 2026-07-10 |
| Recall number | Z-1298-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TELEFLEX MEDICAL INC (Z-1298-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87346/
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