Baxter 15-liter peritoneal dialysis drain bags recalled without FDA clearance
Baxter Healthcare Corporation is recalling 510 units of 15-liter peritoneal dialysis drain bags that were distributed without required FDA regulatory clearance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall with no reported illnesses or injuries. However, peritoneal dialysis drain bags are critical medical devices used in essential treatment, and products without FDA regulatory clearance represent an unreviewed risk-of-harm situation that meets the threshold for High severity.
Plain-English summary
Baxter Healthcare Corporation is recalling certain 15-liter peritoneal dialysis drain bags because they lack FDA regulatory clearance. These products were distributed to consumers in the United States in error without the required FDA approval.
Approximately 510 units were affected. The recalled products are identified by product code R5C4145P and include lot numbers H17H14104, H20K02117, and H21H24081. Products were distributed nationwide across California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio.
Peritoneal dialysis drain bags are medical devices critical to dialysis treatment. Products without FDA regulatory clearance have not undergone FDA review for safety and effectiveness. Consumers with affected units should contact Baxter Healthcare Corporation for further information regarding this recall.
The recalled product
- Product
- 15 Liters Drain Bag
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- unapproved-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 (5)
- Product code: R5C4145P
- UDI: 05413760005386
- Lot Numbers: H17H14104 (exp. date: 07/31/2022)
- H20K02117 (exp. date: 11/02/2025)
- H21H24081 (exp. date: 08/24/2026)
Distribution
Distributed nationwide across the United States.
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