Locking Cap for PD Catheter Adapter Distributed Without FDA Clearance
Baxter Healthcare is recalling locking caps for peritoneal dialysis catheters that were distributed without FDA regulatory clearance. These devices were released into the U.S. market in error.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a medical device distributed without regulatory clearance. The hazard is regulatory non-compliance rather than a known product defect or demonstrated safety risk.
Plain-English summary
Baxter Healthcare Corporation is recalling locking caps for peritoneal dialysis catheter adapters. The recalled product is identified by Product Code R5C4169 with UDI 00085412008639 and Lot Number H20K02067 (expiration date: October 31, 2025).
The devices were distributed without obtaining the required FDA regulatory clearance. Approximately 75 units were distributed nationwide to healthcare facilities in California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio.
Peritoneal dialysis is a critical renal replacement therapy for patients with kidney failure. The distribution of these unapproved devices was made in error.
The recalled product
- Product
- Locking Cap for PD Catheter Adapter
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- unapproved-medical-device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product code: R5C4169
- UDI: 00085412008639
- Lot Number: H20K02067 (exp. date: 10/31/2025)
Distribution
Distributed nationwide across the United States.
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