Z-1935-2012 Class II Terminated
FDA device recall Z-1935-2012 was initiated by Greiner Bio-One North America, Inc. on April 2, 2012 and is designated Class II. Reason for recall: : 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. The recall status is terminated (terminated February 27, 2013). Affected quantity: 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total).
Recall Details
- Product Type
- Devices
- Report Date
- July 11, 2012
- Initiation Date
- April 2, 2012
- Termination Date
- February 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
Product Description
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.
Reason for Recall
: 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.
Distribution Pattern
Nationwide Distribution including IL, MS, OH, PA, TN and VA.
Code Information
Item #450239, Lot #G110601I and Item #450235, Lot #G110302J.