FDA-Device2021-02-17Class II
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.
Baxter Healthcare Corporation
Hazard
There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Sold states
Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
Affected count
66,800 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2021Don't want to check this manually?
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