[pending] EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 3
Pending LLM rewrite. Source: FDA_DEVICE Z-2320-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
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
- Manufacturer
- BERLIN HEART GMBH
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- REF/UDI-DI/serial number: P10P-001/04260090040102/2230714
- 2230709
- P30P-001x01/04260090040126/2230254
Distribution
Distributed nationwide across the United States.
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