Official recall notice
FDA DeviceClass IINotable
FDA Recall: Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 6
- Recall date
- 2026-03-11
- Brand
- Vascutek, Ltd.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
Recommended action
What to do
37430
Product description
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.