FDAFDA · Food and drugs·Recall number Z-1145-2022
3,65 m Extension Set with Luer-lock Connector
Published June 8, 2022 · Recall initiated: April 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
- Lot
- Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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