Prodimed Plastimed Division product recalled over sterility concerns
- Recall date
- May 27, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Prodimed Plastimed Division recalls Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code…
- Recall number
- Z-2492-2020
- FDA classification
- Class II
- Brand / firm
- Prodimed Plastimed Division
- Sold / distributed
- Nationwide
Why it was recalled
Lack of assurance of sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
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