Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
FDA device recall Z-0078-2008 · posted 2007-10-31 · Terminated
Recall details
- Recalling firm
- Gambro BCT, Inc.
- Reason for recall
- Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
- Action taken
- All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the information.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LKN
- Quantity affected
- 15 units
- Distribution
- US, Canada, Australia, Europe.
- Date initiated
- 2007-09-18
- Date posted
- 2007-10-31
- Date terminated
- 2008-01-25
- Location
- Lakewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 (K071079) | Gambro Bct, Inc. | 2007-08-02 |