Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in 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, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
Enforcement
- Recall Number
- Z-1959-2019
- Event ID
- 82986
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Applied Medical Resources Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2019
- Initiation Date
- January 28, 2019
- Classification Date
- July 11, 2019
- Termination Date
- June 12, 2020
- Address
- 22872 Avenida Empresa, Rancho Santa Margarita, CA, 92688-2650, United States
Description
Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in 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, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3
Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland
2,016 units