BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device (VAD) System Blood
See all recalls from BERLIN HEART GMBH →Recalled Product
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Hazard / Issue
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for EXCOR Pediatric Ventricular Assist →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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