FDA Device recall Z-1298-2021
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drai…
- FDA Device
- Class II
- terminated
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drai… by Teleflex Medical, citing teleflex is recalling this product due to a lack of assurance of sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1298-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-12 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex Medical |
| Distribution | US |
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.
Reason
Teleflex is recalling this product due to a lack of assurance of sterility.
Identifiers
| code_info | Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Teleflex Medical
- (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile
FDA Device · Class II · 2022-06-01 · Teleflex Medical - (1) Teleflex Flex tube, Product #20011, sterile
FDA Device · Class II · 2022-06-01 · Teleflex Medical - Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Per…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-…
FDA Device · Class I · 2022-02-23 · Teleflex Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1298-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.