Baxter Recalls DIANEAL Low Calcium Peritoneal Dialysis Solution Due to Container Defect
Baxter Healthcare is recalling 39,486 containers of DIANEAL Low Calcium with Dextrose peritoneal dialysis solution because defective containers may leak when the closure is removed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (peritoneal dialysis solution) where a container defect could lead to contamination or loss of medication, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Baxter Healthcare Corp. is recalling 39,486 containers of DIANEAL Low Calcium with Dextrose (Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride and Dextrose) peritoneal dialysis solution. The product is a 5,000 mL prescription-only container manufactured by Baxter Healthcare Corporation in Deerfield, IL. The specific product code is L5B4826, lot number C886820, with an expiration date of 11/14.
The recall was initiated due to a defective container issue. There is a potential for frangible components to be broken, which can result in a leak at the port when the closure is removed. This defect affects the integrity of the container used for intraperitoneal administration.
The affected product was distributed nationwide and in Puerto Rico. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be stopped and returned to the pharmacy or supplier for replacement or refund.
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 Corp.
- Hazard
- Affected units
- 39,486
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 (3)
- Product Code: L5B4826
- Lot #: C886820
- Exp 11/14
Distribution
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