Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra Optia Apheresis System, a blood
FDA device recall Z-2674-2011 · posted 2011-06-28 · Terminated
Recall details
- Recalling firm
- Caridian BCT, Incorporated
- Reason for recall
- An additional air detection system is being added to all existing systems to detect air in the system's return line.
- Action taken
- CaridianBCT sent a "MEDICAL DEVICE RECALL" letter dated December 2010 to all customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were advised to continue using their systems as long as they followed the instructions in the Operator's Manual. An Acknowledgement of Receipt form was included with the letter to be completed and faxed to 1-303-876-9277 or e-mailed to Regulatory.Affairs@caridianbct.com. A CaridianBCT representative will schedule a visit to facilities to upgrade their systems within the next 6 months. Further information is available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LKN
- Quantity affected
- 594 units
- Distribution
- Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and V
- Date initiated
- 2010-12-09
- Date posted
- 2011-06-28
- Date terminated
- 2011-09-12
- Location
- Lakewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRA OPTIA R APHERESIS SYSTEM (K103090) | Caridianbct, Inc.. | 2010-11-19 |
| SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 (K071079) | Gambro Bct, Inc. | 2007-08-02 |