Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a ...
FDA Device Recall #Z-1876-2018 — Class II — December 19, 2017
Recall Summary
| Recall Number | Z-1876-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 19, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nipro Medical Corporation |
| Location | Doral, FL |
| Product Type | Devices |
| Quantity | 307,944 units. |
Product Description
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
Reason for Recall
There is a possibility of the heparin line is occluded.
Distribution Pattern
US Distribution to the states of : GA, NY, TN, TX.
Lot / Code Information
Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.
Other Recalls from Nipro Medical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0912-2026 | Class II | Hemodialysis System, Surdial DX REF: MC+SDX01 ... | Oct 27, 2025 |
| Z-0161-2016 | Class II | Nipro Safe Touch TULIP Safety Fistula Needle, F... | Aug 13, 2015 |
| Z-0624-2016 | Class II | NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemod... | Mar 30, 2015 |
| Z-0599-2016 | Class III | NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ... | Apr 1, 2014 |
| Z-1834-2014 | Class II | NIPRO Safe Touch Safety Scalp Vein Set | May 4, 2013 |
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.