CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B0155
FDA device recall Z-1634-2014 · posted 2014-05-19 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing accep
- Action taken
- On 5/9/14, TCVS placed a phone call to the one affected customer regarding the recall. The phone call explained the reason for the recall, identification of affected product, potential hazard, and instructions for return of affected product.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- DRY
- Quantity affected
- 1
- Distribution
- one customer in IA
- Date initiated
- 2014-05-09
- Date posted
- 2014-05-19
- Date terminated
- 2014-07-11
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K972962) | 3M Company | 1997-11-06 |