SeriousFDAOngoing
Can cause serious illness or death. Do not eat it.
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Check your package for
All Lots within Expiry/GTIN:00885672009786/00813502010558
- Why
- Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- Distributed
- Distribution in the US state of MA
- Company
- Oscor Inc.
- Announced
- Recall began