Reported Jun 5, 2019 · Terminated
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
Terumo Medical Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Medical Corporation · 950 Elkton Blvd · Elkton, MD · 21921-5322
Is this the product you have?
Portico Solo Re-Collapsible Access SystemModel Numbers PRTSOLO-19PRTSOLO-20
- Lot codes and dates
- Lot Codes
VG29VH28VK09VM20VN08VP07WM03WM31VG05VG09VG21VK18VL25VM11VN17VN27WM03WM17
- Lot Codes
- Amount recalled
- 1481
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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