DLP Pediatric One-Piece Arterial Cannulae recalled over labeling errors
- Recall date
- December 12, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
- Recall number
- Z-0984-2025
- FDA classification
- Class II
- Brand / firm
- Medtronic Perfusion Systems
- Sold / distributed
- Worldwide - US Nationwide distribution.
Why it was recalled
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
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