Medical device recalls Moderate risk

Karl Storz Endoscopy recalls FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

Recall date
February 20, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2425-2019
FDA classification
Class II
Brand / firm
Karl Storz Endoscopy
Sold / distributed
US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA

Why it was recalled

The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

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

What was recalled

FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

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