Recall Z-1959-2019— Applied Medical Resources Corp

Name: FDA recall Z-1959-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-28

Class II · Terminated

Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2019-01-28, terminated 2020-06-12. It names 2 FDA 510(k) clearances: K083638, K041795. 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: The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents..

Recalling firm: Applied Medical Resources Corp
Classification: Class II
Status: Terminated
Initiated: 2019-01-28
Terminated: 2020-06-12
Firm location: Rancho Santa Margarita, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K083638 — FIXATION TROCARSApplied Medical Resources Corp.·cleared 2008-12-23
K041795 — MODIFICATION TO OPTICAL SEPARATOR SYSTEMApplied Medical Resources Corp.·cleared 2004-09-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.