Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93...
FDA Device Recall #Z-1227-2015 - Class II, December 29, 2014
Recall Summary
| Recall Number | Z-1227-2015 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 29, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Corporation Englewood |
| Location | Englewood, CO |
| Product Type | Devices |
| Quantity | 1,404,230 |
Product Description
Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.
Reason for Recall
Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.
Distribution Pattern
Nationwide Distribution
Lot / Code Information
All DiscPac products are affected within expiry up to October 2017
Other Recalls from Baxter Corporation Englewood
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0007-2017 | Class I | 0.2 Micron Filter, 50 mm Product Usage: The... | Aug 24, 2016 |
| 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-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.