FDA recall Z-1959-2019

Applied Medical Resources Corp · Class II · 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.

Reason for recall

The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.

Distribution

Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland

Key facts

Status
Terminated
Initiation date
2019-01-28
Report date
2019-07-17
Termination date
2020-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rancho Santa Margarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1959-2019