Z-0835-2013 Class II Terminated
FDA device recall Z-0835-2013 was initiated by Greiner Bio-One North America, Inc. on Feb 1, 2013 and is designated Class II. 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. The recall status is terminated (terminated Oct 29, 2013). Affected quantity: 192,000 pieces (192 cases).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2013
- Initiation Date
- Feb 1, 2013
- Termination Date
- Oct 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192,000 pieces (192 cases)
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.
Distribution Pattern
US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
Code Information
Lot No. 12H27