Recall Z-0209-2009
Drummond Scientific Co · initiated August 1, 2008
Product
Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
Codes / lots: Lot numbers 8121 exp 6/10, 8142 exp 7/10, & 8165 exp 8/10 and Catalog number 59-000857-002 G - Lot number 8200 exp 9/10
Reason for recall
presence of OSCS contaminant
FDA-determined cause: Material/Component Contamination
Action taken
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.
Details
- Recall number
- Z-0209-2009
- Initiated
- August 1, 2008
- Posted by FDA
- November 7, 2008
- Terminated
- December 18, 2008
- Product code
- GIO – Tube, Collection, Capillary Blood
- Quantity
- 4000 vials
- Distribution
- Nationwide Distribution --- including states of FL and MA.
- Recalling firm
- Drummond Scientific Co, Broomall, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0208-2009 | Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive…presence of OSCS contaminant | 08/01/2008Terminated |
| Z-0210-2009 | Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107.…presence of OSCS contaminant | 08/01/2008Terminated |
| Z-0211-2009 | Separation Technology ClearCRIT Capillary Tubes 75mm/1.1mm ID. Catalog number 270-106.…presence of OSCS contaminant | 08/01/2008Terminated |