Baxter Integrated APD Set Recalled for Potential Cassette Leaks
Baxter Healthcare is recalling L5C4531 X1 Integrated APD Sets because cassettes may leak, risking sterile fluid path contamination and peritonitis.
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 risk-of-harm product where injury has not yet been reported, specifically the potential for peritonitis due to contamination.
Plain-English summary
Baxter Healthcare Corporation is recalling the L5C4531 X1 Integrated APD Set with Cassette 3-Prong. The product is a sterile, nonpyrogenic fluid path sterilized by ethylene oxide. The recall involves 8,640 units from Lot Number H18D22030.
The recall is due to a potential presence of leaks from the cassettes, which may occur due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms, which may predispose the patient to peritonitis.
The affected units were distributed in the United States to the following states and districts: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, and NV. There was no foreign distribution. Consumers and healthcare providers should stop using the affected product and contact Baxter Healthcare Corporation for further instructions.
The recalled product
- Product
- L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
- 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)
- Lot Number H18D22030
Distribution
Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighBaxter Integrated APD Set Recalled for Leakage Complaints
FDA (Devices) · 2015-02-11
- HighBaxter Peritoneal Dialysis Set Recalled for Reported Leaks
FDA (Devices) · 2017-01-25
- SevereBaxter MiniCap PD Transfer Set Recalled for Connection Leak Risk
FDA (Devices) · 2017-06-14
- HighBaxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures
FDA (Devices) · 2023-12-20
- HighBaxter MiniCap PD Transfer Sets Recalled for Chemical Damage Risk
FDA (Devices) · 2022-02-16
- HighBaxter PD Transfer Set Recall: Risk of Leaking or Cracking
FDA (Devices) · 2022-02-16