Baxter Peritoneal Dialysis Set Recalled for Reported Leaks
Baxter Healthcare is recalling 8,640 APD Set with Cassette 3-Prong Peritoneal Dialysis Sets due to customer complaints about leaks.
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 is classified as FDA Class II, and the hazard involves a functional defect (leaks) in a critical medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Baxter Healthcare Corporation is recalling 8,640 units of the APD Set with Cassette 3-Prong Peritoneal Dialysis Set. This medical device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
The recall was initiated due to customer complaints regarding the presence of leaks in the product. The affected units are identified by the code H16F16088 and were distributed only within the United States.
Patients and healthcare providers using this specific dialysis set should stop using the affected units and contact Baxter Healthcare Corporation for further instructions or replacement.
The recalled product
- Product
- APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 8,640
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)
- H16F16088
Distribution
Distribution scope not specified by the agency.
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