FDA recall Z-1291-2024

Baxter Healthcare Corporation · Class II · device

Product

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

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-02-08
Report date
2024-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1291-2024