Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ...
FDA Device Recall #Z-0085-2015 — Class I — September 16, 2014
Recall Summary
| Recall Number | Z-0085-2015 |
| Classification | Class I — Serious risk |
| Date Initiated | September 16, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corp |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 20448 |
Product Description
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Reason for Recall
Particulate matter found inside the fluid path.
Distribution Pattern
Nationwide Distribution including Puerto Rico, and the country of Canada.
Lot / Code Information
Product code 2B8013 Lot Number: UR13K14095
Other Recalls from Baxter Healthcare Corp
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|---|---|---|---|
| Z-3133-2017 | Class II | Baxter Amia Automated Peritoneal Dialysis Set w... | Sep 1, 2017 |
| Z-1839-2016 | Class II | COSEAL Surgical Sealant Kit, 4 mL, Product Code... | May 12, 2016 |
| Z-1840-2016 | Class II | COSEAL Surgical Sealant Kit, 8 mL, Product Code... | May 12, 2016 |
| Z-1838-2016 | Class II | COSEAL Surgical Sealant Kit, 2 mL, Product Code... | May 12, 2016 |
| Z-0132-2016 | Class II | ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXT... | May 21, 2015 |
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.