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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 06, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 30, 2004
Recall NumberZ-0975-04
Recall Event ID 29092
Product Classification Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use - Product Code JQC
ProductCustomized Automation Centrifuge, First and Second Generation.
Code Information First Generation: OPIC0004, HAND0007, HAND0008, HAND0011, HAND0012, U9507151, U9507152, U9507153.  Second Generation: 2028, 2030, 2032, 2033, 2034, 2038, 2039, 2040.
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers.
FDA Determined
Cause 2		Other
ActionRecall was by letter and by telephone. All customers have been contacted.
Quantity in Commerce17
DistributionNationwide
Total Product Life CycleTPLC 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.
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