Baxter Healthcare Corporation 2023-09-06 Health serious FDA
Health · FDA · Recall #FDA-D-1141-2023
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll… Recall
Issued September 6, 2023 · Baxter Healthcare Corporation
In September 2023, Baxter Healthcare Corporation recalled the Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
What you should do
- 1 Stop using Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Baxter Healthcare Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Baxter Healthcare Corporation
- Category
- Health
- Recall date
- September 6, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-1141-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Baxter Healthcare Corporation has 36 recalls in our database, including 5 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.