Drug recall
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1…
FDA recall event 68354 · Class II · NxStage Medical, Inc.
Key facts
| Event ID | 68354 |
|---|---|
| Recall numbers | Z-1854-2014, Z-1855-2014, Z-1856-2014, Z-1857-2014, Z-1858-2014, Z-1859-2014, Z-1860-2014, Z-1861-2014 |
| Recalling firm | NxStage Medical, Inc. |
| Product type | Devices |
| Products | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters)…, NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, Batch Size…, NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size…, NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60…, NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40 and 3 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| Initiation date | May 14, 2014 |
| Report date | Jul 2, 2014 |
| Termination date | Mar 13, 2017 |
| City | Lawrence |
| State | MA |
| Country | United States |
| FEI number | 3003464075 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: