Recall record at a glance
| Official record | Z-1132-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | NxStage Medical, Inc. |
| Report date | Mar 28, 2018 |
| Recall initiation date | Nov 10, 2017 |
| Quantity | 1243400 units |
| Location | Lawrence, MA, United States |
Official product description
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Why the product was recalled
Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
Distribution information
US nationwide distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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