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PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

Class I - Dangerous
🏥 Medical Devices Recalled: November 15, 2019 Tytek Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
  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:
Tytek Medical Inc
Reason for Recall:
A defect involving an occluded needle was discovered during a training exercise.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

Product Codes/Lot Numbers:

NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0930-2020

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