Recall Z-0371-2023— Bunnell, Inc.
Class II · Ongoing
Class II FDA medical device recall by Bunnell, Inc., initiated 2022-11-02. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Bunnell, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-02
- Firm location
- Salt Lake City, UT, United States
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.