Baxter recalls APD Drain Manifolds with specific product codes due to FDA regulatory clearance errors. Affected units were distributed in the US without proper clearance.
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Baxter Healthcare is recalling certain APD Drain Manifolds that were distributed in the US without FDA regulatory clearance. This means the product may not meet safety standards and could pose risks if used.
The product was distributed in the US without FDA regulatory clearance, meaning it may not meet safety standards. This could lead to potential risks if the device is used without proper regulatory approval.
Peritoneal dialysis patients and healthcare providers who own or use the recalled APD Drain Manifolds with the listed product codes and lot numbers. Those using the product without proper clearance are at risk.
Check for the product code R5C4512, UDI 00085412008790, and lot numbers H18D03030 (exp. 04/03/2023), H18E31046 (exp. 05/31/2023), H18L04065 (exp. 12/04/2023), or H20H10073 (exp. 08/10/2022).
Identify the product code, UDI, and lot numbers to confirm if your APD Drain Manifold is affected.
The product was distributed in the US without FDA regulatory clearance, which means it may not meet safety standards.
The recall record does not specify a remedy, so contact Baxter Healthcare for guidance.
Yes, affected lot numbers include H18D03030 (exp. 04/03/2023), H18E31046 (exp. 05/31/2023), H18L04065 (exp. 12/04/2023), and H20H10073 (exp. 08/10/2022).
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1146-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1146-2022 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.
