Exact FDA event identifier

Event 82986

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: January 28, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Applied Medical Resources Corp

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Recall number: Z-1959-2019
Initiated: January 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Applied Medical Resources Corp
Quantity: 2,016 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

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.

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