🔍 RecallPedia

TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303

Class I - Dangerous
🏥 Medical Devices Recalled: October 5, 2020 Tytek Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI: 00855204008006 All lots produced prior to Oct 5, 2020
  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:
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303

Product Codes/Lot Numbers:

UDI: 00855204008006 All lots produced prior to Oct 5, 2020

Distribution:

Distributed in: OH, SC, VA, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2610-2023

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