FDA Device recall Z-0371-2023
2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025
- FDA Device
- Class II
- ongoing
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of 2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025 by Bunnell, citing some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0371-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-02 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bunnell |
| Distribution | US |
Product
2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938
Reason
Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.
Identifiers
| code_info | Catalog/UDI/Lot: 9025/10616120000034/22042320 ; and 2.5 mm LifePort Endotracheal Tube Adaptors, Lot: 22042320, inside 9…Catalog/UDI/Lot: 9025/10616120000034/22042320 ; and 2.5 mm LifePort Endotracheal Tube Adaptors, Lot: 22042320, inside 938/10616120000089, 00616120000082/22052381, 22052407, 22062431, 22062458, 22062478 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0371-2023%22
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