Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
Hazard
Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
What You Should Do
Remedy
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.
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Products
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
- Brand
- Gambro BCT, Inc.
- UPC
- Part No. 61000, Serial Numbers 1P00100 to 1P00141.
Units Affected
15 units