Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of w...
FDA Device Recall #Z-1443-2014 — Class II — March 17, 2014
Recall Summary
| Recall Number | Z-1443-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 17, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smiths Medical ASD, Inc. |
| Location | Rockland, MA |
| Product Type | Devices |
| Quantity | 393,210 |
Product Description
Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Reason for Recall
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.
Lot / Code Information
2509489 2509490 2509491 2509491 2509493 2513256 2513257 2513258 2513259 2513259 2523835 2528502 2528503 2528505 2531609 2531609 2536970 2536971 2536972 2540530 2540531 2540531 2540533 2540534 2540535 2540536 2540537 2540537 2549516 2553479 2553480 2553481 2558317 2558317 2558324 2563120 2563123 2567637 2567638 2567638 2567640 2572571 2573607 2576408 2577526 2577526 2585112 2585113 2586060 2588651 2588652 2588652 2590076 2597393 2597394 2600985 2602457 2602457 2602460 2607387 2607389 2607390 2610674 2610674 2614827 2615844 2615845 2615846 2620953 2620953 2620957 2621091 2621096
Other Recalls from Smiths Medical ASD, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1667-2025 | Class I | CADD-Solis HPCA Ambulatory Infusion Pump; Mode... | Apr 10, 2025 |
| Z-1681-2025 | Class I | CADD-Solis Infusion Pump Models: 1) PUMP KIT,... | Apr 10, 2025 |
| Z-1668-2025 | Class I | CADD-Solis VIP Ambulatory Infusion Pump; Mode... | Apr 10, 2025 |
| Z-1662-2025 | Class I | CADD Solis HSPCA Pump | Apr 10, 2025 |
| Z-1682-2025 | Class I | CADD Solis VIP Ambulatory Infusion Pump Models:... | Apr 10, 2025 |
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.