Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core tempera...
FDA Device Recall #Z-0407-2013 — Class II — August 17, 2012
Recall Summary
| Recall Number | Z-0407-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 17, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vital Signs Colorado Inc. |
| Location | Englewood, CO |
| Product Type | Devices |
| Quantity | 243,685 units |
Product Description
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
Reason for Recall
There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.
Lot / Code Information
Model Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers: 12089A 12131A 5575A 5586X 5633U 5664E 5685G 5712T 12090B 12138A 5578K 5603R 5636Y 5666R 5685H 5714Z 12100A 12157B 5578L 5606U 5638P 5668N 5685J 12101B 12173A 5580Y 5614N 5638Q 5669G 5689Y 12102A 5573Q 5580Z 5615N 5648T 5669H 5691T 12108B 5574A 5581A 5621U 5648U 5671D 5692H 12109B 5574B 5581L 5623H 5653Z 5673V 5696Q 12114B 5574X 5583E 5631C 5658D 5683V 5700J 12117B 5574Y 5584C 5632V 5660C 5683W 5703N 12130B 5574Z 5584D 5633T 5664D 5683X 5708R
Other Recalls from Vital Signs Colorado Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1557-2015 | Class II | Introduction Pack. A device inserted into an e... | Mar 13, 2015 |
| Z-1556-2015 | Class II | CareFusion Vital Signs LightWand Stylet. A d... | Mar 13, 2015 |
| Z-0812-2014 | Class II | Vital Signs Anesthesia Circuits The Ventilat... | Dec 26, 2013 |
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.