Applied Medical Resources Corp: Medical Device Recall in 2019 - (Recall #: Z-1959-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: January 28, 2019

Date Posted: July 17, 2019

Recall Number: Z-1959-2019

Event ID: 82986

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.

Status: Terminated

Product Quantity: 2,016 units

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

Voluntary or Mandated:

Voluntary: Firm initiated