Baxter Healthcare recalls a 3,65m extension set with Luer-lock connector due to unapproved FDA regulatory clearance for peritoneal dialysis use in the US. Affected units have specific product codes and lot numbers.
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Baxter Healthcare is recalling a 3,65m extension set with Luer-lock connector used in peritoneal dialysis because it was distributed without FDA approval. This could pose risks if used in medical procedures without proper regulatory clearance.
The extension set was distributed in the US without FDA regulatory clearance for peritoneal dialysis use. This means it may not meet safety standards required for medical procedures, potentially leading to complications if used improperly.
Peritoneal dialysis patients and healthcare providers who own or use the recalled extension set with the specific product code R5C4480F and lot number H19G12025 are affected. Patients using this product without FDA clearance may face risks.
Check for the product code R5C4480F and lot number H19G12025 on the extension set. The expiration date for this lot is July 12, 2024.
Verify the product code R5C4480F and lot number H19G12025 on the extension set.
The extension set was distributed in the US without FDA regulatory clearance for peritoneal dialysis use.
The recall record does not specify a remedy, so check the product details to confirm if it's affected.
The recall indicates unapproved regulatory clearance, but the record does not describe specific injury risks.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1145-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1145-2022 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
