Recall Z-0835-2013— Greiner Bio-One North America, Inc.
Class II · Terminated
Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2013-02-01, terminated 2013-10-29. It names one FDA 510(k) clearance: K011786. Product: VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.. Reason: The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece..
- Recalling firm
- Greiner Bio-One North America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-01
- Terminated
- 2013-10-29
- Firm location
- Monroe, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
Reason for recall
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Data sourced from openFDA. This site is unofficial and independent of the FDA.