Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
FDA Device Recall #Z-2646-2020 — Class II — May 28, 2020
Recall Summary
| Recall Number | Z-2646-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 28, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Carefusion 2200 Inc |
| Location | Vernon Hills, IL |
| Product Type | Devices |
| Quantity | N/A |
Product Description
Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
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.
Distribution Pattern
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.
Lot / Code Information
Catalog: OTP5000; UDI: 50885403284746; Batches 0001319437, 0001320128, 0001321277, 0001321728, 0001322907, 0001324316, 0001332577, 0001334404, 0001335108, 0001336587, 0001337314, 0001338451, 0001339415, 0001341205, 0001342585, 0001344650, 0001346669, 0001346992
Other Recalls from Carefusion 2200 Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2429-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAM... | Jul 13, 2023 |
| Z-2421-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 5... | Jul 13, 2023 |
| Z-2418-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENE... | Jul 13, 2023 |
| Z-2417-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GR... | Jul 13, 2023 |
| Z-2420-2023 | Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY... | Jul 13, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.