GEM — Class II medical device recall Z-1630-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-05-18, distributed nationwide. Instructions for use booklet may puncture the outer Tyvek lid.
| Recall number | Z-1630-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2016-04-21 |
| Classified | 2016-05-09 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2016-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, DK, GB, IL, NL, SE |
| Quantity | 288 units |
| Model numbers | GEM2755-FC |
Product
GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-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 intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
Reason for recall
Instructions for use booklet may puncture the outer Tyvek lid.
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-1630-2016. 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.