MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and ...
FDA Device Recall #Z-1008-2015 — Class I — December 4, 2014
Recall Summary
| Recall Number | Z-1008-2015 |
| Classification | Class I — Serious risk |
| Date Initiated | December 4, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Teleflex, Inc. |
| Location | Wayne, PA |
| Product Type | Devices |
| Quantity | 18 |
Product Description
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
Reason for Recall
Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
Distribution Pattern
Distributed in the states of FL, MI, WV, and KS.
Lot / Code Information
Batch Numbers: 201321, 201323, and 201324.
Other Recalls from Teleflex, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1124-2015 | Class II | R¿SCH Curved Reinforced Endotracheal Tube: Rusc... | Dec 12, 2014 |
| Z-2411-2015 | Class II | Carlens Bronchial Double Lumen Tube Set (Left) ... | Nov 21, 2014 |
| Z-2408-2015 | Class II | Bronchial Double Lumen Tube Set (Right), Sterile | Nov 21, 2014 |
| Z-2409-2015 | Class II | Bronchial One Lumen Tube - Left | Nov 21, 2014 |
| Z-2407-2015 | Class II | Bronchial Double Lumen Tube Set (Left), Sterile | Nov 21, 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.