FlowCOUPLER — Class II medical device recall Z-2126-2014
Terminated recall by Baxter Healthcare Corporation, reported 2014-08-06, distributed nationwide. Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not m
| Recall number | Z-2126-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Westlake Village, CA, United States |
| Recall initiated | 2014-07-11 |
| Classified | 2014-07-29 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2015-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, DK, ES, GB, IL, SE |
| Quantity | 1,315 units |
| Lot numbers | SPSGT13-10J0016, SPSGT13-10J0017, SPSGT13-10J0018, SPSGT13-11K0039, SPSGT13-11K0040, SPSGT13-11K0041, SPSGT13-11K0042, SPSGT13-12L0007, SPSGT13-12L0008, SPSGT13-12L0012, SPSGT13-12L0015, SPSGT14-01A0009, SPSGT14-01A0027, SPSGT14-01A0028, SPSGT14-02B0026, SPSGT14-02B0027A, SPSGT14-02B0028, SPSGT14-02B0033, SPSGT14-04D0005, SPSGT14-04D0014, SPSGT14-04D0015, SPSGT14-04D0023, SPSGT14-04D0026, SPSGT14-04D0027, SPSGT14-05E0005 |
| Model numbers | 5151-01200-010, 5151-01200-011, 5151-01250-010, 5151-01250-011, 5151-01300-010, 5151-01300-011 |
Product
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.
Reason for recall
Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.
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-2126-2014. 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.