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U.S. Department of Health and Human Services

Class 2 Device Recall Kii Fios Advanced fixation Access System

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 Class 2 Device Recall Kii Fios Advanced fixation Access Systemsee related information
Date Initiated by FirmJanuary 28, 2019
Create DateJuly 11, 2019
Recall Status1 Terminated 3 on June 12, 2020
Recall NumberZ-1959-2019
Recall Event ID 82986
510(K)NumberK041795 K083638 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductKii 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.
Code Information Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3
FEI Number 2027111
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information ContactLauren Contursi
949-713-8767
Manufacturer 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.
FDA Determined
Cause 2		Packaging
ActionEach 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.
Quantity in Commerce2,016 units
DistributionWorldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GCJ
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