Baxter Healthcare recalls certain unapproved peritoneal dialysis effluent sample bags distributed in the US due to missing FDA clearance. Affected products include specific lot numbers with expiration dates through 2026.
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Baxter Healthcare is recalling specific peritoneal dialysis effluent sample bags that were distributed in the US without proper FDA regulatory clearance. This recall affects patients using these bags for peritoneal dialysis treatments, as the unapproved product could pose risks if used without regulatory approval.
The recalled effluent sample bags were distributed without FDA regulatory clearance, meaning they were not approved for safety and effectiveness in medical use. This could lead to potential risks if used without proper regulatory oversight, though the exact hazard is not specified in the recall notice.
Patients using peritoneal dialysis treatments with the recalled effluent sample bags are most at risk. The recall applies to specific lot numbers distributed within the United States.
Check for the product code R5C4476 on the bag. Look for specific lot numbers: H18E25030 (exp. 04/30/2023), H19D12097 (exp. 03/31/2024), H19K14040 (exp. 10/31/2024), and other listed lots with expiration dates through 2026.
Verify the product code R5C4476 and specific lot numbers listed in the recall notice to confirm if your bag is affected.
The recall is due to certain effluent sample bags being distributed in the US without FDA regulatory clearance, meaning they were not approved for medical use.
The recall notice does not specify a remedy, so check the product details to see if your bag is affected and contact Baxter Healthcare for further guidance.
The recall states the product was distributed without FDA clearance, but the exact risks are not described in the notice. The hazard level is unknown.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1144-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1144-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
