Z-1959-2019Class II

Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021...

Name: Z-1959-2019 Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021...
Creator: Applied Medical Resources Corp
Published: 2019-01-28
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2019-01-28 / Terminated / root cause: packaging

FDA source

Applied Medical Resources Corp began a recall of 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... on 2019-01-28. FDA classified it as Class II and gives the reason as "The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1959-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-28
Posted: 2019-07-11
Terminated: 2020-06-12
Recalling firm: 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: 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 [email protected] or faxing it to (949) 713-8205. - Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical.
Quantity in commerce: 2,016 units
Distribution: Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland
Product codes and lots: Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1959-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1959-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-17	2019-07-11

Product code GCJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)