BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnos
FDA device recall Z-0160-2016 · posted 2015-10-23 · Terminated
Recall details
- Recalling firm
- LifeHealth, LLC
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 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,
- Date initiated
- 2015-09-16
- Date posted
- 2015-10-23
- Date terminated
- 2016-03-21
- Location
- Roseville, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IRMA BLOOD ANALYSIS SYSTEM (K945240) | Diametrics Medical, Inc. | 1995-01-05 |