Peritoneal Dialysis Extension Sets Recalled for Missing FDA Clearance
Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.
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 classified as FDA Class II. Although no illnesses or injuries have been reported, the product was distributed without required FDA regulatory clearance, making it a risk-of-harm product that warrants a High severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling the 3.65 m Extension Set with Luer-lock Connector (Product Code: R5C4480F). This recall affects 60 units from Lot Number H19G12025, which has an expiration date of July 12, 2024.
These extension sets were distributed in the United States in error because they do not have FDA regulatory clearance.
The recalled devices were distributed nationwide in the states of California, Missouri, Massachusetts, Arizona, Texas, Florida, New York, Maryland, and Ohio.
Healthcare facilities and individuals who have these devices should not use them. Contact Baxter Healthcare Corporation for instructions on how to return or dispose of the recalled extension sets.
The recalled product
- Product
- 3,65 m Extension Set with Luer-lock Connector
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- unapproved-device
- regulatory-non-compliance
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: R5C4480F
- UDI: 00085412577142
- Lot Number: H19G12025 (exp. date: 07/12/2024)
Distribution
Distributed nationwide across the United States.
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