Z-1291-2024 Class II Ongoing
FDA device recall Z-1291-2024 was initiated by Baxter Healthcare Corporation on Feb 8, 2024 and is designated Class II. Reason for recall: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber. The recall status is ongoing. Affected quantity: 26,592 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2024
- Initiation Date
- Feb 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,592 units
Product Description
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Reason for Recall
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 00085412565767, Lot Number R23A02062, exp. 1 Jan 2025
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1291-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026