Class II — Baxter Healthcare Corp.
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Instructions for use booklet may puncture the outer Tyvek lid. |
| Product | GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is in… |
| Quantity | 630 units |
| Distribution | Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada |
| Initiated | 2016-04-21 |
| Classified | 2016-05-09 |
| Terminated | 2016-11-22 |
| Recall number | Z-1628-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corp. (Z-1628-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73908/
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