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Recall Observatory FDA recall evidence

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.

Z-1102-2021

December 21, 2020

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 87056
Status
Terminated
Classification
Class II
Quantity
66,800 units
Official record key
device-enforcement:Z-1102-2021

Official wording

Reason: There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There were customer reports of separation between the tubing and Male Luer Lock Adaptor.