FDA Device recall Z-1102-2021
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm…
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm… by Baxter Healthcare, citing there were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1102-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-21 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | UDI: 00085412613505, Lot Numbers: DR18E01023, exp. 5/2/2023; DR18E07053, exp. 5/8/2023; DR19G08023, exp. 7/8/2024; DR…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1102-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.