Baxter recalls certain Peritoneal Dialysis Locking Caps due to FDA regulatory clearance errors. Affected units were distributed in error within the U.S. No action is required as the product is not cleared for use.
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 Locking Caps that were distributed without FDA regulatory clearance. This means the product was sold in the U.S. without proper approval, but no action is needed as the product is not intended for use.
The product was distributed in the U.S. without FDA regulatory clearance, meaning it was not approved for use. This could pose a risk if used without proper approval, but the product is not intended for use in the first place.
Peritoneal dialysis patients who own the specific product code R5C4169 with lot number H20K02067 are affected. Patients using this model should check if they have the recalled item.
Check for product code R5C4169, lot number H20K02067 (expires 10/31/2025), or UDI 00085412008639. The product is a Locking Cap for PD Catheter Adapter.
Identify if your Locking Cap for PD Catheter Adapter has product code R5C4169 and lot number H20K02067.
No action is required as the product was distributed without FDA clearance but is not intended for use.
The lot number H20K02067 expires on 10/31/2025.
The product was not approved for use by the FDA, so it is not intended for use.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1142-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1142-2022 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.
