Thora-Para 5 Fr Catheter Drainage Tray recallZ-2657-2020 · Carefusion 2200 Inc · initiated May 28, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carefusion 2200 Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2657-2020
- Status
- Terminated
- Initiated by the company
- May 28, 2020
- Recalling firm
- Carefusion 2200 Inc
- Product code
- PXI
- 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.
Product description
Thora-Para 5 Fr Catheter Drainage Tray
Code information (models, lots, serial numbers)
Catalog: TPT1005 UDI: 50885403220850; Batches: 0001320127, 0001323274, 0001333152, 0001335109, 0001339556, 0001345011
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA TPT1005Carefusion 2200, Inc · Thoracentesis tray1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 85751).
- Z-2646-2020 · TerminatedThora-Para 5 Fr Non-Valved Catheter Drainage Tray
- Z-2647-2020 · TerminatedSafe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
- Z-2648-2020 · TerminatedSafe-T-Centesis 6 Fr Catheter Drainage Tray
- Z-2649-2020 · TerminatedSafe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
- Z-2650-2020 · TerminatedSafe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
- Z-2651-2020 · TerminatedSafe-T-Centesis 8 Fr Catheter Drainage Tray
- Z-2652-2020 · TerminatedSafe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
- Z-2653-2020 · TerminatedThora-Para 8 Fr Catheter Drainage Tray
- Z-2654-2020 · TerminatedThora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
- Z-2655-2020 · TerminatedSafe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
- Z-2656-2020 · TerminatedSafe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
- Z-2658-2020 · TerminatedSafe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
- Z-2659-2020 · TerminatedSafe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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