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Recall Observatory FDA recall evidence

Device product

CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401

Z-1291-2024

February 08, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 93930
Status
Ongoing
Classification
Class II
Quantity
26,592 units
Official record key
device-enforcement:Z-1291-2024

Official wording

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 information: UDI/DI 00085412565767, Lot Number R23A02062, exp. 1 Jan 2025

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.