FDA Enforcement
Class II
Ongoing
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Recall: Z-1291-2024
·
Reported March 20, 2024
Enforcement
- Recall Number
- Z-1291-2024
- Event ID
- 93930
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 20, 2024
- Initiation Date
- February 8, 2024
- Classification Date
- March 14, 2024
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
Description
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Reason
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.
Code Info
UDI/DI 00085412565767, Lot Number R23A02062, exp. 1 Jan 2025
Distribution
US Nationwide distribution.
Quantity
26,592 units