Recall Z-0160-2016 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
LifeHealth, LLC
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.
| Date | Oct 23, 2015 (initiated Sep 16, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a LifeHealth "Urgent Medical Device Recall" letter dated September 16, 2015. The letter described the problem and the product involved in the recall. The letter described the Risk to Health, Action to be taken and Other Information. Consignees were advised to discontinue use and destroy all stock on hand. Requested consignees to complete and return the Verification Form to LifeHealth. For additional information contact Nancy Ring at 1-855-762-8978 or 651-638-1000, Monday through Friday, 8:30 AM to 4:30 PM, Central Time or see our website at www.lifehealthmed.com. |
| Quantity | 1735 boxes of 25. (43375 Cartridges) |
| Distribution | 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, IREL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945240 | IRMA BLOOD ANALYSIS SYSTEM Diametrics Medical, Inc., Jan 5, 1995 |