Baxter Recalls Peritoneal Dialysis Solution Due to Incorrect Inspection Instructions
Baxter Healthcare is recalling Extraneal and DIANEAL Low Calcium peritoneal dialysis solutions because a technical service representative provided incorrect instructions for inspecting solution bags.
The agency’s classification
FDA (Devices): 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 3/5 (High).
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 medical device used for life-sustaining treatment where incorrect instructions could lead to the use of defective equipment, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Baxter Healthcare Renal Division is recalling Extraneal and DIANEAL Low Calcium Peritoneal Dialysis Solution in Plastic Container, PL-146. This product is used with the Automated Peritoneal Dialysis System (Automated PD Set with Cassette) and the HomeChoice dialysis system, which is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients.
The recall was initiated because Baxter discovered that a technical service representative was providing incorrect instructions for the inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette. The recall covers all lots and serial numbers of the affected product.
The product was distributed nationwide, including in Arizona, California, Ohio, Pennsylvania, and Virginia. Patients using these dialysis solutions should contact their healthcare provider or Baxter Healthcare for further instructions on how to proceed with their treatment.
The recalled product
- Product
- Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system…
- Manufacturer
- Baxter Healthcare Renal Div
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 (1)
- all lots and serial numbers
Distribution
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