Teleflex Medical Europe Ltd
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2321-2021 | Class II | RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 11208005 | July 16, 2021 |
| Z-2319-2021 | Class II | RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170 | July 16, 2021 |
| Z-2320-2021 | Class II | RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 50 | July 16, 2021 |
| Z-2322-2021 | Class II | RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 1120 | July 16, 2021 |
| Z-2287-2018 | Class II | Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical | June 12, 2018 |
| Z-1403-2018 | Class II | Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usa | March 27, 2018 |
| Z-1628-2018 | Class II | Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Inte | March 19, 2018 |
| Z-1368-2018 | Class II | Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Recta | March 15, 2018 |
| Z-1367-2018 | Class II | Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 | March 15, 2018 |
| Z-1369-2018 | Class II | Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 5 | March 15, 2018 |
| Z-1370-2018 | Class II | Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 65 | March 15, 2018 |