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U.S. Department of Health and Human Services

Class 2 Device Recall Spectra Optia

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  Class 2 Device Recall Spectra Optia see related information
Date Initiated by Firm September 18, 2007
Date Posted October 31, 2007
Recall Status1 Terminated 3 on January 25, 2008
Recall Number Z-0078-2008
Recall Event ID 44915
510(K)Number K071079  
Product Classification apheresis system, a blood component separator - Product Code LKN
Product Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
Code Information Part No. 61000, Serial Numbers 1P00100 to 1P00141.
Recalling Firm/
Manufacturer		 Gambro BCT, Inc.
10811 W Collins Ave
Lakewood CO 80215-4440
For Additional Information Contact
303-231-4180
Manufacturer Reason
for Recall		 Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 15 units
Distribution US, Canada, Australia, Europe.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LKN and Original Applicant = GAMBRO BCT, INC.
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