Product Wiki · Recalls · Health Canada — Medical Devices

Vascuteks' various Gelweave, ePTFE, SEALPTFE, Thin Wall Fluoropassiv… — recall 57606

Health Canada — Medical Devices · Canada · 2018-01-12 · Type III

As described by Health Canada — Medical Devices: Vascuteks' various Gelweave, ePTFE, SEALPTFE, Thin Wall Fluoropassiv, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS and GelsealERT Vascular Prosthesis (2017-12-13)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
57606
Date of alert
2018-01-12
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: To inform customers about updates to the Instructions for Use (IFU) for the listed gelatin sealed products. These updates now mandate soaking prostheses/patches in sterile saline solution for 5 minutes prior to implantation and include information on the use of formaldehyde in the manufacturing process.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vascuteks-various-gelweave-ept

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