LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Re...
FDA Device Recall #Z-1479-2014 — Class II — February 25, 2014
Recall Summary
| Recall Number | Z-1479-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hospira Inc. |
| Location | Lake Forest, IL |
| Product Type | Devices |
| Quantity | 3,893 sets |
Product Description
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.
Reason for Recall
Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.
Distribution Pattern
US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
Lot / Code Information
Product List Number: 112410403; Lot Numbers: 280055H, 341005H
Other Recalls from Hospira Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1832-2016 | Class II | The Plum 360 is a large volume infuser capable ... | Mar 25, 2016 |
| Z-1833-2016 | Class II | The Plum A+ is a dual-line volumetric infusion ... | Mar 25, 2016 |
| Z-0863-2016 | Class II | The Symbiq infusion pump is a device used in a ... | Dec 22, 2015 |
| Z-1074-2015 | Class I | The Plum A+ Infusion System is designed to meet... | Jul 2, 2014 |
| Z-1073-2015 | Class I | The Plum A+ Infusion System is designed to meet... | Jul 2, 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.