Atlas FDA

Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1

FDA device recall Z-1498-06 · posted 2006-09-13 · Terminated

Recall details

Recalling firm
Greiner Bio-One North America, Inc.
Reason for recall
Coagulation tubes found with no additive.
Action taken
Consignees were notified by letter via fax starting 08/02/2006.
Root cause
Other
Status
Terminated
Product code
GIM
Quantity affected
160 cases (192000 pieces)
Distribution
Nationwide
Date initiated
2006-08-02
Date posted
2006-09-13
Date terminated
2007-01-11
Location
Monroe, NC

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Related 510(k) clearances

RecordFirmDate
GREINER VACUETTE BLOOD COLLECTION TUBE (K971221)Greiner America, Inc.1997-05-02