Kii Fios First Entry…

Date

July 17, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Applied Medical Resources Corp

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.

Distribution pattern

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

Quantity

2,016 units

Codes and lots

Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3

Recall started

Jan. 28, 2019

Device type

Laparoscope, General & Plastic Surgery

Root cause (FDA)

Packaging

What the company told customers

Each US customer was notified via, "Urgent: Medical Device Recall" letter sent via UPS on January 28, 2019. All international consignees are in the process of being notified. The firm request customers compete the following actions: - Check your inventory for recalled product. - Complete the attached Recall Notification Confirmation Form (Page 2) to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above. - If no product is being returned, please indicate on the Recall Notification Confirmation Form - If you are a distributor, please notify any facilities to which you distributed the affected product. Please also complete Page 3 of the Recall Notification Confirmation Form. - Return the Recall Notification Confirmation Form to Applied Medical by emailing it to recall60790124@appliedmedical.com or faxing it to (949) 713-8205. - Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical.

Recall number

Z-1959-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1959-2019. The agency record governs; check it and the company before acting.