CLASS II Device recall · Reported 11 May 2022 · FDA Enforcement Report

Flo-Thru Intraluminal Shunt recalled by Baxter Healthcare

Baxter Healthcare is recalling Flo-Thru Intraluminal Shunt, distributed in 7 states. The recall was initiated on 1 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: FT12150; Lot: SP21J21-1584173

Quantity recalled300 devices

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-1019-2022
FDA event ID: 89897
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 1 Apr 2022
FDA classified: 29 Apr 2022
Reported: 11 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

1 Apr 2022	Recall initiated by company
29 Apr 2022	Classified by FDA	+28 days
11 May 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for foreign matter.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.

Where it was distributed

Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom

Alabama California Kentucky New York Oregon Pennsylvania Texas

Questions about this recall

Why was it recalled?

There is a potential for foreign matter.

Which lots are affected?

Product Code: FT12150; Lot: SP21J21-1584173

Where was it sold?

Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom

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 26 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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