Official recall notice
FDA DeviceClass IINotable
FDA Recall: Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ5
- Recall date
- 2026-06-24
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Recommended action
What to do
49,654 kits total
Product description
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.