Recall Z-2658-2020
Carefusion 2200 Inc · initiated May 28, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
Codes / lots: Catalog: TPT1005SDF UDI: 50885403228139; Batches: 0001333153 and 0001339557
Reason for recall
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
FDA-determined cause: Under Investigation by firm
Action taken
All affected consignees are being notified via FedEx mailed letter and/or email beginning 6/15/2020. BD requests a sub-recall to be conducted if product has been further distributed. Consignees are asked to complete the acknowledgement form included with the notification letter and return to BD.
Details
- Recall number
- Z-2658-2020
- Initiated
- May 28, 2020
- Terminated
- September 20, 2024
- Product code
- PXI – Thoracentesis Tray
- Distribution
- 370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.
- Recalling firm
- Carefusion 2200 Inc, Vernon Hills, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2646-2020 Class II | Thora-Para 5 Fr Non-Valved Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2647-2020 Class II | Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2648-2020 Class II | Safe-T-Centesis 6 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2649-2020 Class II | Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o LidocaineThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2650-2020 Class II | Safe-T-Centesis PLUS 6 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2651-2020 Class II | Safe-T-Centesis 8 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2652-2020 Class II | Safe-T-Centesis PLUS 8 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2653-2020 Class II | Thora-Para 8 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2654-2020 Class II | Thora-Para 8 Fr Catheter Drainage Tray w/o LidocaineThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2655-2020 Class II | Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug FreeThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2656-2020 Class II | Safe-T PLUS Thora-Para 8 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2657-2020 Class II | Thora-Para 5 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2659-2020 Class II | Safe-T PLUS Thora-Para 5 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |