Applied Medical Resources recalls Kii Fios First Entry surgical devices (Lot 1330981, exp July 2021) due to potential non-sterility, risking patient infection. Affected users should contact the company for details.
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
Applied Medical Resources is recalling Kii Fios First Entry surgical devices that may not have met sterility standards. Using these devices could expose patients to infections during surgery.
The product may not have met sterility requirements, meaning it could be contaminated. Using a non-sterile device on a patient during surgery may expose them to infectious agents.
Healthcare professionals using the Kii Fios First Entry devices for surgical procedures. Patients undergoing surgery with these devices are at risk of infection.
Check for the lot number 1330981 and expiration date July 15, 2021 on the device packaging. The product is labeled as 'Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05'.
Reach out to Applied Medical Resources Corp for specific instructions on handling the recalled product.
The product may not have met sterility requirements, which could expose patients to infectious agents during surgery.
Contact Applied Medical Resources Corp for specific instructions on handling the recalled product.
No, using this product may expose patients to infections due to potential non-sterility.
We’ve drafted a message you can send Applied Medical Resources to request your refund or repair — edit it as you like.
Subject: Recall Z-1959-2019 — Applied Medical Resources Applied Medical Resources Hello, I own a Applied Medical Resources that is covered by recall Z-1959-2019 from Applied Medical Resources. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
