FDA-Device2013-01-16Class II

Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Applied Medical Resources Corp
Hazard

Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.

Sold states
Worldwide Distribution - USA (nationwide) and France.
Affected count
72 units
Manufactured in
22872 Avenida Empresa # 3, Rancho Santa Margarita, CA, United States
Products
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0644-2013

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