Z-1145-2022 Class II Terminated
FDA device recall Z-1145-2022 was initiated by Baxter Healthcare Corporation on Apr 21, 2022 and is designated Class II. Reason for recall: Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. The recall status is terminated (terminated May 27, 2026). Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2022
- Initiation Date
- Apr 21, 2022
- Termination Date
- May 27, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
3,65 m Extension Set with Luer-lock Connector
Reason for Recall
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Distribution Pattern
US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Code Information
Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1145-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026