Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0210-2009

Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology...

Drummond Scientific Co / initiated 2008-08-01 / Terminated / root cause: manufacturing process

Drummond Scientific Co began a recall of Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL... on . The reason FDA records is "presence of OSCS contaminant". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0210-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Drummond Scientific Co
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.
Product code
GIO Tube, Collection, Capillary Blood
Reason for recall
presence of OSCS contaminant
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
Lot number 1058