Medical device recalls Moderate risk

Applied Medical Resources Corp recalls Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14)…

Recall date
May 4, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2533-2017
FDA classification
Class II
Brand / firm
Applied Medical Resources Corp
Sold / distributed
US and worldwide: Australia, Finland, France, United Kingdom

Why it was recalled

Due to possibility of insufficient sterilization.

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

What was recalled

Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

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