Reported Jul 17, 2019 · Terminated
Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied…
Applied Medical Resources Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
- Kii Fios First Entry, 5 X 75 mm, RX only
- REF CFF05 Qty6, Sterile R
- Lot1330981
- Exp
July 152021Applied Medical Resource Corp
- Product UsageKii 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
- Lot codes and dates
- Lot1330981
- Exp
July 152021
- UDI0 0607915 12312 3
- Amount recalled
- 2,016 units
Where it was sold
- Nationwide
Why it was recalled
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
This product could cause temporary or reversible health problems — stop using it.
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