Recall Z-0179-2012 ยท FMI Needle, Hypodermic, Single Lumen
Greiner Bio-One North America, Inc.
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.
| Date | Nov 9, 2011 (initiated Aug 11, 2011) |
| Status | Terminated |
| Reason | Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 443,950 pieces |
| Distribution | Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102774 | VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER Greiner Bio-One North America, Inc., Oct 15, 2010 |