BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, d...
FDA Device Recall #Z-0160-2016 — Class II — September 16, 2015
Recall Summary
| Recall Number | Z-0160-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 16, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | LifeHealth, LLC |
| Location | Roseville, MN |
| Product Type | Devices |
| Quantity | 1735 boxes of 25. (43375 Cartridges) |
Product Description
BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
Reason for Recall
May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
Distribution Pattern
US: Nationwide (AL, AR, CA, CO, FL, IL, IN, IA, KS, KY, MD, MA,MI, MN, MS, MO, NE, NJ, NY,NC, OH, OK, PA, TN, TX, VA) OUS: ALBANIA, BELGIUM, BOLIVIA, CANADA, CHILE, CHINA, DENMARK. DOMINICAN REPUBLIC, ECUADOR, EGYPT, ENGLAND, ESTONIA, PHILIPPINES, FRANCE, GERMANY, GREECE, ICELAND, INDONESIA, IRELAND, ITALY, JAMAICA, JAPAN, MOROCCO, NETHERLANDS, NORWAY, PERU, PORTUGAL, SOUTH AFRICA, SOUTH KOREA, SPAIN, TAIWAN, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VIETNAM.
Lot / Code Information
EOSCU EOTUZ EOVMW EOYUL EPANW EPCED EPDVM EPFOJ EPIXX EPKOJ EPNXA
Other Recalls from LifeHealth, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0159-2016 | Class II | CC cartridges for IRMA TRUPOINT Blood Gas Analy... | Sep 16, 2015 |
| Z-1919-2015 | Class II | LifeHealth, IRMA TRUPOINT model 443914, typical... | Apr 29, 2015 |
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.