CLASS II Device recall · Reported 18 May 2016 · FDA Enforcement Report
Gem(tm), Flowcoupler(r), Sterile Eo recalled by Baxter Healthcare
Baxter Healthcare is recalling Gem(tm), Flowcoupler(r), Sterile Eo, distributed nationwide in the US. The recall was initiated on 21 Apr 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1629-2016
- FDA event ID
- 73908
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Apr 2016
- FDA classified
- 9 May 2016
- Reported
- 18 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 21 Apr 2016 | Recall initiated by company | |
| 9 May 2016 | Classified by FDA | +18 days |
| 18 May 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Instructions for use booklet may puncture the outer Tyvek lid.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-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.
Where it was distributed
Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
Questions about this recall
Is Gem(tm), Flowcoupler(r), Sterile Eo recalled?
Yes. Baxter Healthcare recalled Gem(tm), Flowcoupler(r), Sterile Eo on 21 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1629-2016.
Why was it recalled?
Instructions for use booklet may puncture the outer Tyvek lid.
Which lots are affected?
SP15H05-1067841 thru SP15L02-1102423
Where was it sold?
Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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