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Baxter Healthcare Corporation Recall 87056

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.

Baxter Healthcare Corporation Recall 87056 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1102-2021
Event ID87056
Event DescriptionBaxter 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.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
Quantity66,800 units
Recall ReasonThere were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Device Classification20210217
Device Code InfoUDI: 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
Center Classification Date20210209
Recall Initiation Date20201221
Recalling FirmBaxter Healthcare Corporation
Initial Notification E-Mail
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