Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set — Class II medical device recall Z-1102-2021
Terminated recall by Baxter Healthcare Corporation, reported 2021-02-17, distributed nationwide. There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
| Recall number | Z-1102-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-12-21 |
| Classified | 2021-02-09 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2024-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, IE |
| Quantity | 66,800 units |
| UPC / GTIN / UDI-DI | 00085412613505 |
| Lot numbers | DR18E01023, DR18E07053, DR19G08023, DR19H07015, DR19L09030, DR20B04020 |
| Model numbers | 7N8370K |
| Expiration dates | 2023-05-02, 2023-05-08, 2024-07-08, 2024-08-07, 2024-12-10, 2025-02-05 |
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 for recall
There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1102-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.