Enforcement Report - Week of January 23, 2013
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Product Detail
| Product Description | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. |
|---|---|
| Recall Number | Z-0678-2013 |
| Classification | Class III |
| Code Info | Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006, |
| Product Distributed Qty | 14,240 units |
| Reason For Recall | GranuFlo Dry Acid Concentrate may show discoloration |
Event Detail
| Event Id | 63768 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| City | Waltham |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-26 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution |
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