Atlas FDA

Vacuette, Safety Blood Collection Set with Luer Adapter

FDA device recall Z-0797-03 · posted 2003-05-09 · Terminated

Recall details

Recalling firm
Greiner VACUETTE North America
Reason for recall
The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
Action taken
Consignees were notified via certified letter on/about 3/6/2003 and were advised to stop distributing the product immediately and to discard any remaining product in stock.
Root cause
Other
Status
Terminated
Product code
JKA
Quantity affected
139000 units
Distribution
Product was distributed to medical facilities Nationwide.
Date initiated
2003-03-10
Date posted
2003-05-09
Date terminated
2003-08-07
Location
Monroe, NC

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Related 510(k) clearances

RecordFirmDate
VACUETTE SAFETY BLOOD COLLECTION SET (K011786)Greiner Vacuette North America, Inc.2001-07-12