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 catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm…

Recall number

Z-2489-2020

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 catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US