Z-1102-2021 Class II Terminated
FDA device recall Z-1102-2021 was initiated by Baxter Healthcare Corporation on Dec 21, 2020 and is designated Class II. Reason for recall: There were customer reports of separation between the tubing and Male Luer Lock Adaptor. The recall status is terminated (terminated Jul 11, 2024). Affected quantity: 66,800 units.
Recall details
- Product Type
- Devices
- Report Date
- Feb 17, 2021
- Initiation Date
- Dec 21, 2020
- Termination Date
- Jul 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66,800 units
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.
Distribution pattern
Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1102-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026