Kii Fios First Entry recall: Sterility Concern
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…
Why was Kii Fios First Entry 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3
- 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…
- Recalling firm
- Applied Medical Resources Corp
- Quantity
- 2,016 units
- Distribution
- Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland
- Recall date
- July 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)