Device product
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.
Z-1959-2019
Product summary
- Event
- Event 82986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,016 units
- Official record key
device-enforcement:Z-1959-2019
Official wording
Reason: The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
Code information: Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3
Distribution pattern: Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland
Derived failure modes
-
Unknown
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.