ClearanceBrief
Recall Z-1498-06 ยท GIM Tubes, Vacuum Sample, With Anticoagulant

Greiner Bio-One North America, Inc.

Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA

DateSep 13, 2006 (initiated Aug 2, 2006)
StatusTerminated
ReasonCoagulation tubes found with no additive.
Root causeOther
ActionConsignees were notified by letter via fax starting 08/02/2006.
Quantity160 cases (192000 pieces)
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K971221GREINER VACUETTE BLOOD COLLECTION TUBE
Greiner America, Inc., May 2, 1997