FDA-Device2017-06-21Class II

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

Applied Medical Resources Corp
Hazard

Due to possibility of insufficient sterilization.

Sold states
US and worldwide: Australia, Finland, France, United Kingdom
Affected count
7,939 units total (870 units in US)
Manufactured in
22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, United States
Products
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2533-2017

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