Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
This recall has been terminated (originally issued November 9, 2011).
- Recall Initiated
- August 11, 2011
- Posted
- November 9, 2011
- Terminated
- March 20, 2012
- Recall Number
- Z-0179-2012
- Quantity
- 443,950 pieces
- Firm Location
- Monroe, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
Distribution
Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA.
Lot / Code Info
Item #450254, Lot numbers: B041104, B051105 and B071106.
Root Cause
Nonconforming Material/Component
Action Taken
Greiner Bio-One sent a "QUICKSHIELD WITH SAFETY HOLDER" notification letter dated August 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to stop distributing and using the affected products. A Product Disposition Form was attached for customers to complete and return for replacements. Contact the firm at 888-266-3883 for questions concerning this recall.