Portico Solo Re-Collapsible Access System recall
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
Why was Portico Solo Re-Collapsible Access System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17
- Product
- Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
- Recalling firm
- Terumo Medical Corporation
- Quantity
- 1481
- Distribution
- The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.
- Recall date
- June 5, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)