CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and
FDA device recall Z-0142-2012 · posted 2011-10-31 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored.
- Action taken
- Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" notice dated September 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides information on what to do in the event of a failure of the device. Additionally, a Customer Response Form was attached to the letter for customers to complete and return. Terumo CVS will schedule the return of affected products for inspection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DRY
- Quantity affected
- 432
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Chile, Japan, Philippines, and Thailand.
- Date initiated
- 2011-09-23
- Date posted
- 2011-10-31
- Date terminated
- 2013-04-11
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K972962) | 3M Company | 1997-11-06 |