Home / Recalls / Bunnell, Inc. / Z-0371-2023

Z-0371-2023 Class II Ongoing

Recalled by Bunnell, Inc. — Salt Lake City, UT

Recall Details

Product Type: Devices
Report Date: December 14, 2022
Initiation Date: November 2, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1606 Assemblies

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.

Distribution Pattern

US Nationwide Distribution: PA, NY, AR, AZ, TN, SC, MA, FL, CA, TX, MD, VA, NV, IL, IN, IA, HI, KY, LA, WI, GA, OH, MI, MO, MN, NJ, MS, NC, ND, NM, UT, OK, WA, RI; OUS: Canada

Code Information

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