Baxter Healthcare recalls 15L drain bags with FDA regulatory clearance errors. Affected units have specific product codes and lot numbers. Consumers should contact Baxter for details.
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Baxter Healthcare is recalling 15-liter drain bags that were distributed without FDA regulatory clearance. This error means the products may not meet safety standards and could pose risks during medical use.
The drain bags were distributed without proper FDA regulatory clearance. This means they may not meet safety standards for medical use, potentially causing complications during peritoneal dialysis.
Patients using peritoneal dialysis with the recalled drain bags are affected. Healthcare providers who use these bags in medical treatments are at higher risk.
Check for product code R5C4145P, lot numbers H17H14104 (exp. 07/31/2022), H20K02117 (exp. 11/02/2025), or H21H24081 (exp. 08/24/2026). These bags were sold in the U.S. with specific expiration dates.
Identify the product code R5C4145P and lot numbers listed in the recall notice.
The drain bags were distributed without FDA regulatory clearance, meaning they may not meet safety standards for medical use.
The recall notice does not specify a remedy; contact Baxter Healthcare for further instructions.
Yes, the recalled bags have expiration dates: 07/31/2022, 11/02/2025, and 08/24/2026.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1141-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1141-2022 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.
