Terumo Portico Solo Re-Collapsible Access System Recalled for Tip Dislodgement
Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Terumo Medical Corporation is recalling 1,481 units of the Portico Solo Re-Collapsible Access System, Model Numbers PRTSOLO-19 and PRTSOLO-20. The recall was initiated because there is a potential for the tip to dislodge from the outer diameter of the sheath. This defect can result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
The affected products were distributed nationwide in the United States and in the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, and Singapore. The specific lot codes associated with this recall are VG29, VH28, VK09, VM20, VN08, VP07, WM03, WM31, VG05, VG09, VG21, VK18, VL25, VM11, VN17, VN27, WM03, and WM17.
Healthcare providers and patients should stop using the affected devices and contact Terumo Medical Corporation for further instructions on how to return or replace the products.
The recalled product
- Product
- Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 1,481
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Terumo Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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