ClearanceBrief
Recall Z-0797-03 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Greiner VACUETTE North America

Vacuette, Safety Blood Collection Set with Luer Adapter

DateMay 9, 2003 (initiated Mar 10, 2003)
StatusTerminated
ReasonThe needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
Root causeOther
ActionConsignees 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.
Quantity139000 units
DistributionProduct was distributed to medical facilities Nationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K011786VACUETTE SAFETY BLOOD COLLECTION SET
Greiner Vacuette North America, Inc., Jul 12, 2001