Official recall notice
FDA DeviceClass IINotable
FDA Recall: Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
- Recall date
- 2026-09-23
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Product description
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Affected products
UDI-DI 10195327506506 Lot 25BBK494