FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes — Class II medical device recall Z-0939-2021
Ongoing recall by Baxter Healthcare Corporation, reported 2021-02-10, distributed nationwide. Potential for the battery to lose its ability to be recharged.
| Recall number | Z-0939-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-12-28 |
| Classified | 2021-01-30 |
| Reported by FDA | 2021-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 109 units |
| UPC / GTIN / UDI-DI | 00135306000284, 00135306000291, 00136959000317, 00136959000324, 00136959000331, 00136959000348, 00136959000355, 00136959000362, 00139609000583, 00139609000606, 00844735006148 |
| Serial numbers | 135306000279, 135306000280, 135306000281, 135306000282, 135306000283, 135306000284, 135306000286, 135306000287, 135306000288, 135306000289, 135306000290, 135306000291, 135306000292, 135306000293, 135306000294, 135306000295, 135306000298, 135306000299, 135306000300, 135306000301, 135306000303, 135306000304, 135306000305, 135591000306, 135591000307 and 84 more |
Product
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
Reason for recall
Potential for the battery to lose its ability to be recharged.
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-0939-2021. 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.