United StatesAbiomed introducer kits REF 0052-3025, 0052-3021, and 0052-3006 for the Impella Hemostatic Peel Away Introducer System with Infusion Sideport (14F — 13 cm and 25 cm; 14F and 23F; and 23F), all lots within expiry with the listed GTINs, distributed by Oscor Inc. in Massachusetts. They were recalled because manufacturing issues can cause the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines.
What's being recalled
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Recalling firm: Oscor Inc., Palm Harbor, FL, United States.
How to identify it
All Lots within Expiry/GTIN:00885672009793, 00813502010664 All Lots within Expiry/GTIN:00885672009786/00813502010558 All Lots within Expiry/GTIN:00885672009755/00813502011609
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distribution in the US state of MA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)