Baxter Healthcare Corporation 2022-05-11 Health serious FDA
Health · FDA · Recall #FDA-Z-1019-2022
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures.… Recall
Issued May 11, 2022 · Baxter Healthcare Corporation
In May 2022, Baxter Healthcare Corporation recalled the Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures.…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is a potential for foreign matter.
What you should do
- 1 Stop using Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures.… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Baxter Healthcare Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Baxter Healthcare Corporation
- Category
- Health
- Recall date
- May 11, 2022
- Units affected
- Not reported
- Sold at
- Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and
- Recall number
- FDA-Z-1019-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Baxter Healthcare Corporation has 36 recalls in our database, including 5 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.