Drug recall
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number…
FDA recall event 68135 · Class III · Fresenius Medical Care Holdings, Inc.
Key facts
| Event ID | 68135 |
|---|---|
| Recall numbers | Z-1739-2014 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Product type | Devices |
| Products | NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Container cap may contain foreign material- 0.60% - 0.80% Manganese |
| Initiation date | May 1, 2014 |
| Report date | Jun 18, 2014 |
| Termination date | Jun 15, 2016 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
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: