Atlas FDA

Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in tot

FDA device recall Z-1331-04 · posted 2004-08-10 · Terminated

Recall details

Recalling firm
Greiner VACUETTE North America
Reason for recall
Coagulation tubes may not have received the proper fill of citrate solution.
Action taken
Consignees were notified by letter on 7/28/2004.
Root cause
Other
Status
Terminated
Product code
GIM
Quantity affected
314 cases (376,800 pieces)
Distribution
Nationwide
Date initiated
2004-07-27
Date posted
2004-08-10
Date terminated
2004-10-29
Location
Monroe, NC

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Related 510(k) clearances

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