Portex 100/105/035

• FDA 510(k) K790312 decided 21 Feb 1979 Active
• FDA GUDID UDI-DI 15019315018657 listed 1 Sep 2015 Listed

• • Ongoing Z-1289-2025 FDA Class I ·initiated 13 Feb 2025

  Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

• 4 recalls, same reason

  • Terminated Z-2538-2014 FDA Class I ·initiated 7 Jul 2014
  • Terminated Z-2537-2014 FDA Class I ·initiated 7 Jul 2014
  • Terminated Z-2539-2014 FDA Class I ·initiated 7 Jul 2014
  • Terminated Z-2536-2014 FDA Class I ·initiated 7 Jul 2014

  The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

• • Terminated Z-1641-2014 FDA Class I ·initiated 10 Apr 2014

  One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.

1. 21 Feb 1979 Cleared FDA 510(k) K790312
2. 10 Apr 2014 Recall initiated FDA recalls Z-1641-2014
3. 7 Jul 2014 Recall initiated FDA recalls Z-2538-2014
4. 7 Jul 2014 Recall initiated FDA recalls Z-2537-2014
5. 7 Jul 2014 Recall initiated FDA recalls Z-2539-2014
6. 7 Jul 2014 Recall initiated FDA recalls Z-2536-2014
7. 1 Sep 2015 Listed FDA GUDID 15019315018657
8. 13 Feb 2025 Recall initiated FDA recalls Z-1289-2025

Trade name

Portex

Generic name

Basic endotracheal tube, single-use

Model / reference

100/105/035

Primary DI / UDI-DI

15019315018657

510(k) Number

K790312 ↗

FDA product code

BTR

GMDN term

Basic endotracheal tube, single-use

Device class

Class II

Regulation number

868.5730

GUDID distribution status

In Commercial Distribution

Category: Basic endotracheal tube, single-use

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• Bivona FT26JN30NGF219N

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  FDA 510(k) K923878 Active Cleared 29 Dec 1992 GUDID on market

• Bivona HT26JS70NSC222N

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  FDA 510(k) K923878 Active Cleared 29 Dec 1992 GUDID on market

• Bivona HT26JS80NSC205N

  Class II

  FDA 510(k) K923878 Active Cleared 29 Dec 1992 GUDID on market

• Bivona ST26JN55NSA204N

  Class II

  FDA 510(k) K923878 Active Cleared 29 Dec 1992 GUDID on market

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