FDA recall Z-1102-2021

Baxter Healthcare Corporation · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.

Key facts

Status
Terminated
Initiation date
2020-12-21
Report date
2021-02-17
Termination date
2024-07-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2021