2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside

FDA device recall Z-0371-2023 · posted 2022-12-03 · Open, Classified

Recall details

Recalling firm

Bunnell, Inc.

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.

Action taken

On 11/02/22, recall notices were emailed to customers, who were asked to remove the affected adapters and affected adapters from patient circuit kits and discard. The remainder of the Patient Circuit Kit may be retained for future use. As a reminder, customers may use a 3.0 mm LifePort Adapter (included in each Patient Circuit Kit) to connect to a 2.5 mm endotracheal tube if this is the only available product for patient care, per the instructions for use in the User Manual (model 204) and Operator's Manual (model 203). Complete are return the acknowledgement and receipt form. Customers with additional questions are encouraged to call 800-800-4358 or email info@bunl.com

Root cause

Packaging process control

Status

Open, Classified

Product code

LSZ

Quantity affected

1606 Assemblies

Distribution

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

Date initiated

2022-11-02

Date posted

2022-12-03

Location

Salt Lake City, UT