Enforcement Report - Week of July 25, 2012
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Event Detail
| Event ID | 61769 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Becton Dickinson & Co. |
| City | Sparks |
| State | MD |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. | Lot 1348873, Exp April 30, 2013 | Class II | Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci. | 539 kits | Z-2031-2012 |
| Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. | Lots 1325324 Exp May 31,2013 and 2011746, Exp July 31,2013 | Class II | Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci. | 878 cartons/ 3512 bottles | Z-2032-2012 |
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