Z-1653-2022 Class I Terminated
FDA device recall Z-1653-2022 was initiated by Baxter Healthcare Corporation on Aug 9, 2022 and is designated Class I. Reason for recall: Firm noted an increase in customer reports of leaks. The recall status is terminated (terminated Aug 9, 2024). Affected quantity: 511,728 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 21, 2022
- Initiation Date
- Aug 9, 2022
- Termination Date
- Aug 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 511,728 units
Product Description
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Reason for Recall
Firm noted an increase in customer reports of leaks.
Distribution Pattern
US Nationwide Distribution
Code Information
UDI/DI 00085412656649, All lots within expiry
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1653-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026