Official recall notice
FDA DeviceClass INotable
FDA Recall: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
- Recall date
- 2026-04-01
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Recommended action
What to do
368,264
Product description
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.