Baxter Recalls Dianeal Low Calcium Dialysis Solution Due to Sterility Concerns
Baxter Healthcare is recalling 29,370 bags of Dianeal Low Calcium peritoneal dialysis solution because confirmed customer complaints identified leaks in the tubing, compromising sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk contexts (like sterility failure in dialysis) align with a Severe rating, especially given the potential for serious infection from non-sterile dialysis fluid.
Plain-English summary
Baxter Healthcare Corporation is recalling 29,370 bags of Dianeal Low Calcium with Dextrose (2.5 mEq/L) peritoneal dialysis solution. The product is a prescription-only medication used for peritoneal dialysis, distributed nationwide in the USA to wholesalers, distributors, healthcare facilities, and home patients.
The recall was initiated due to a lack of assurance of sterility. Confirmed customer complaints reported leaks on the tubing, which poses a risk of contamination. The affected product is identified by Lot # Y281477 with an expiration date of 02/2020. The specific product code is 5B9766 and the NDC is 0941-0424-52.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider or Baxter Healthcare for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
- Brand
- DIANEAL LOW CALCIUM WITH DEXTROSE
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 29,370
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: Y281477
- Expiry: 02/2020
Distribution
Distributed nationwide across the United States.
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