United StatesEXCOR Pediatric VAD System blood pump PU valves — 10 ml (REF P10P-001; UDI‑DI 04260090040102; serials 2230714, 2230709) and 30 ml (REF P30P-001x01; UDI‑DI 04260090040126; serial 2230254) are affected; distributed in the U.S., including MA and SC. They were recalled because the blood pump inner package expiration date does not match the outer expiration date, which may lead to delays in surgical procedures.
What's being recalled
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Recalling firm: Berlin Heart GMBH, Berlin, N/A, Germany.
How to identify it
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
The hazard
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
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
US Nationwide distribution in the states of MA, SC.
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)