0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate f...
FDA Device Recall #Z-0007-2017 — Class I — August 24, 2016
Recall Summary
| Recall Number | Z-0007-2017 |
| Classification | Class I — Serious risk |
| Date Initiated | August 24, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Corporation Englewood |
| Location | Englewood, CO |
| Product Type | Devices |
| Quantity | 202,647 |
Product Description
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Reason for Recall
Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.
Distribution Pattern
Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
Lot / Code Information
All unexpired lots-Product Code: H93835
Other Recalls from Baxter Corporation Englewood
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0731-2016 | Class II | Baxter, RAPIDFILL Syringe Strip, 10 ml. For us... | Dec 21, 2015 |
| Z-1628-2015 | Class II | ABACUS SE (Single-Workstation Edition) and ABAC... | Apr 8, 2015 |
| Z-1227-2015 | Class II | Baxter, Self-Righting Syringe Tip Caps, Self-Ri... | Dec 29, 2014 |
| Z-0871-2015 | Class II | Self-Righting Luer Lock Tip Cap, Green and Self... | Dec 4, 2014 |
| Z-1847-2014 | Class II | Abacus 3.1, Pharmacy Calculator Product Usag... | May 28, 2014 |
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.