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Teleflex Medical Inc FDA Recalls
11 recalls on file across devices, 7 of them Class I and 2 still open. Matched by name to TFX.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, steriClass IIApr 11, 2022Reports received of torn corrugated breathing tubes. |
| (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterilClass IIApr 11, 2022Reports received of torn corrugated breathing tubes. |
| Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-127Class IJan 11, 2022The firm received reports indicating PTD tip separation duri |
| Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-CClass IJan 11, 2022The firm received reports indicating PTD tip separation duri |
| Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-657Class IJan 11, 2022The firm received reports indicating PTD tip separation duri |
| Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola PerClass IJan 11, 2022The firm received reports indicating PTD tip separation duri |
| Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65Class IJan 11, 2022The firm received reports indicating PTD tip separation duri |
| Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T Class IJan 11, 2022The firm received reports indicating PTD tip separation duri |
| 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-030Class IJan 11, 2022The firm received reports indicating PTD tip separation duri |
| RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is uClass IIFeb 18, 2021Teleflex is voluntarily recalling the products referenced ab |
| PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use deviClass IIFeb 12, 2021Teleflex is recalling this product due to a lack of assuranc |