Berlin Heart EXCOR Pediatric VAD Blood Pump recalled for mismatched expiration dates
Some Berlin Heart EXCOR Pediatric Ventricular Assist Device blood pumps have mismatched expiration dates between the inner and outer package labels. The inner package shows an incorrect expiration date, which could cause confusion and delay surgical procedures if the device is not used on time.
From the FDA notice · Read the official notice ↗
What to do
- Check the inner and outer package expiration dates on any EXCOR Pediatric blood pump (10 ml or 30 ml) in your facility.
- Contact Berlin Heart or your device supplier immediately if you have an affected unit.
- Do not use the device until you have confirmed the correct expiration date with the manufacturer.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
- Sold in
- Nationwide
- Made for
- Children (under 18 years)
Details
- Units affected
- 3
- Illnesses reported
- None reported
- Manufactured in
- Wiesenweg 10, N/A, Berlin, N/A, Germany
- Classification
- Class II
- Recall number
- Z-2320-2026
In the FDA's words
- Description
- EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254 Distribution: US Nationwide distribution in the states of MA, SC. Affected quantity: 3
- Hazard
- Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.