Applied Medical Recalls Kii Fios First Entry Devices for Sterility Concerns
Applied Medical Resources Corp is recalling Kii Fios First Entry devices because they may not have met sterility requirements, potentially exposing patients to infectious agents.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection risk from non-sterile device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Applied Medical Resources Corp is recalling Kii Fios First Entry devices (5 x 75 mm, REF CFF05, Lot 1330981, Exp: July 15, 2021). The recall involves 2,016 units that were distributed worldwide, including in the United States, Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland.
The recall was initiated because the product may not have met sterility requirements. The use of a non-sterile device on a patient may expose the patient to infectious agents. The devices are indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures.
Healthcare providers and patients should stop using the affected devices immediately. The recall is classified as Class II by the FDA.
The recalled product
- 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…
- Manufacturer
- Applied Medical Resources Corp
- Affected units
- 2,016
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot: 1330981
- Exp: July 15
- 2021 UDI: 0 0607915 12312 3
Distribution
Distributed nationwide across the United States.
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