ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product Code: 5-13015, Lot numbers: 01A1000503, 01A1000056, 01B1000243, 01B1000023, 01B1000257, 01E1000404, 01E1000528, 01F1000093, 01G1000243, 01J1000253, 01G1000430, 01M1000283, 01M1000288, 01B1100010, 01C1100226, 01C1100151, 01C1100374, 01E1100100, 01E1100347, 01D1100358, 01C1100488, 01H1100354, 01E1100251, 01B1100463, 01J1100233, 01A1200448, 01C1200084, 01C1200384, 01B1200546, 01C1200467, 01K1100239, 01M1100365, 01E1200319, 01J1100379, 01H1200042, 01F1200035, 01E1200547, 01L1100370, 01J1200073, 01J1200198, 01E1300294, 01E1300322, 01E1300430, 01G1300424, 01G1300095 and 01H1300325, 01J1300002.
  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:
Teleflex Medical
Reason for Recall:
The tracheal tube can kink during patient use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Product Codes/Lot Numbers:

Product Code: 5-13015, Lot numbers: 01A1000503, 01A1000056, 01B1000243, 01B1000023, 01B1000257, 01E1000404, 01E1000528, 01F1000093, 01G1000243, 01J1000253, 01G1000430, 01M1000283, 01M1000288, 01B1100010, 01C1100226, 01C1100151, 01C1100374, 01E1100100, 01E1100347, 01D1100358, 01C1100488, 01H1100354, 01E1100251, 01B1100463, 01J1100233, 01A1200448, 01C1200084, 01C1200384, 01B1200546, 01C1200467, 01K1100239, 01M1100365, 01E1200319, 01J1100379, 01H1200042, 01F1200035, 01E1200547, 01L1100370, 01J1200073, 01J1200198, 01E1300294, 01E1300322, 01E1300430, 01G1300424, 01G1300095 and 01H1300325, 01J1300002.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0953-2014

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