🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: January 28, 2019 Applied Medical Resources Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Applied Medical Resources Corp
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 Codes/Lot Numbers:

Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1959-2019

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Applied Medical Resources

Class I - Dangerous

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

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