Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector...
FDA Recall #Z-1102-2021 — Class II — December 21, 2020
Product Description
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use.
Reason for Recall
There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
66,800 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
Code Information
UDI: 00085412613505, Lot Numbers: DR18E01023, exp. 5/2/2023; DR18E07053, exp. 5/8/2023; DR19G08023, exp. 7/8/2024; DR19H07015, exp. 8/7/2024; DR19L09030, exp. 12/10/2024; DR20B04020, exp. 2/5/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated