Devices

Device Recall Kii Shielded Bladed Access System

Model / Serial
Lot Number: 1179107
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and France.
Product Description
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.
Manufacturer
Applied Medical Resources Corp
1 Event
- Recall of Device Recall Kii Shielded Bladed Access System

Manufacturer

Applied Medical Resources Corp

Manufacturer Address
Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
Manufacturer Parent Company (2017)
Applied Medical Corporation
Source
USFDA

One device with a similar name

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Device Recall Kii Shielded Bladed Access System and Kii Low Profile System

Model / Serial
CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
US and worldwide: Australia, Finland, France, United Kingdom
Product Description
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and || Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Manufacturer
Applied Medical Resources Corp

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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