Recall record at a glance
| Official record | D-1276-2014 |
|---|---|
| Category | Drug Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Baxter Healthcare Corp. |
| Report date | May 7, 2014 |
| Recall initiation date | Feb 11, 2014 |
| Quantity | 27,169 containers |
| Location | Deerfield, IL, United States |
Official product description
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Why the product was recalled
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Distribution information
Nationwide.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement 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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.