Recall Z-1102-2021— Baxter Healthcare Corporation

Name: FDA recall Z-1102-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-21

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-12-21, terminated 2024-07-11. It names one FDA 510(k) clearance: K132734. 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: There were customer reports of separation between the tubing and Male Luer Lock Adaptor..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-12-21
Terminated: 2024-07-11
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSBaxter Healthcare Corp·cleared 2013-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.