Baxter Healthcare recalls 5 Prong Manifold Sets with Luer Connectors due to unapproved FDA regulatory clearance for peritoneal dialysis use in the US. Affected units have specific lot numbers and expiration dates.
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Baxter Healthcare is recalling 5 Prong Manifold Sets with Luer Connectors that were distributed without FDA approval for peritoneal dialysis use. This could pose a risk if used without proper regulatory clearance.
The product was distributed in the US without FDA regulatory clearance, meaning it may not meet safety standards for peritoneal dialysis. Using unapproved medical devices could lead to complications or health issues.
Peritoneal dialysis patients and healthcare providers who own or use the recalled 5 Prong Manifold Sets with Luer Connectors. Patients using the product without FDA clearance may face health risks.
Check for the product code R5C4427, lot numbers H17D26065 (exp. 04/26/2022), H17I18046 (exp. 09/18/2022), H18C20051 (exp. 03/20/2023), or H19J24041 (exp. 10/24/2024).
Identify the lot number and expiration date on the product label to determine if it is affected.
The product 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 see if it is affected.
Yes, affected lot numbers include H17D26065 (exp. 04/26/2022), H17I18046 (exp. 09/18/2022), H18C20051 (exp. 03/20/2023), and H19J24041 (exp. 10/24/2024).
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1143-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1143-2022 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.
