Device product
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
Z-1935-2012
Product summary
- Event
- Event 62447
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
- Official record key
device-enforcement:Z-1935-2012
Official wording
Reason: : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.
Code information: Item #450239, Lot #G110601I and Item #450235, Lot #G110302J.
Distribution pattern: Nationwide Distribution including IL, MS, OH, PA, TN and VA.
Derived failure modes
-
Unknown
: The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.