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
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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 |
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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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