🔍 RecallPedia

Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

Class I - Dangerous
🏥 Medical Devices Recalled: October 12, 2018 Atrium Medical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    ME221275
  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:
Atrium Medical Corporation
Reason for Recall:
This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

Product Codes/Lot Numbers:

ME221275

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0560-2019

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