Enforcement Report - Week of July 11, 2012
-
Back to Previous Page
Event Detail
| Event ID | 62447 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Greiner Bio-One North America, Inc. |
| City | Monroe |
| State | NC |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-02 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including IL, MS, OH, PA, TN and VA. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Item #450239, Lot #G110601I and Item #450235, Lot #G110302J. | Class II | : 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. | 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total) | Z-1935-2012 |
-
