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U.S. Department of Health and Human Services

Class 2 Device Recall Separation Technology ClearCRIT Capillary Tubes 0.5mm ID

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  Class 2 Device Recall Separation Technology ClearCRIT Capillary Tubes 0.5mm ID see related information
Date Initiated by Firm August 01, 2008
Date Posted November 07, 2008
Recall Status1 Terminated 3 on December 18, 2008
Recall Number Z-0210-2009
Recall Event ID 49092
Product Classification Capillary Blood Collection Tube - Product Code GIO
Product Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714.

Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
Code Information Lot number 1058
Recalling Firm/
Manufacturer		 Drummond Scientific Co
500 Parkway
Broomall PA 19008
For Additional Information Contact Bert Moses
610-353-0200
Manufacturer Reason
for Recall		 presence of OSCS contaminant
FDA Determined
Cause 2		 Material/Component Contamination
Action The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.
Quantity in Commerce 1000 vials
Distribution Nationwide Distribution --- including states of FL and MA.
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.
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