Vascuteks' Various Gelweave, Eptfe, Sealptfe, Thin Wall Fluoropassiv, Gelsoft Ers, Gelsoft Plus, Gelsoft Plus Ers And Gelsealert Vascular Prosthesis (2017-12-13)
Recall Summary Vascultek is recalling multiple types of vascular prosthesis products (Gelweave, ePTFE, SEALPTFE, Thin Wall Fluoropassiv, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS, and GelsealERT) distributed across Canada due to a medical device issue. These are surgical implants used in vascular procedures. This is a Class I recall, meaning the product could cause serious health problems or death.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-01-12
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/67fb6fd0-d0bb-42bf-a1aa-84f84cb34e82