Recall Z-0209-2009 ยท GIO Tube, Collection, Capillary Blood
Drummond Scientific Co
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.
| Date | Nov 7, 2008 (initiated Aug 1, 2008) |
| Status | Terminated |
| Reason | presence of OSCS contaminant |
| 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 | 4000 vials |
| Distribution | Nationwide Distribution --- including states of FL and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.