Medical device recalls Moderate risk

Pentax Medical Company recalls Video Duodenoscope

Recall date
February 22, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1835-2016
FDA classification
Class II
Brand / firm
Pentax Medical Company
Sold / distributed
Nationwide

Why it was recalled

Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Video Duodenoscope

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