2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside
Summary
The FDA issued a Class II for 2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm Li by Bunnell, Inc.. 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 su.
Details
Source
Device Recall
External ID
Z-0371-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 1606 Assemblies
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
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-02
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bunnell, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bunnell, Inc. have FDA actions?
This is the only FDA action we have on record for Bunnell, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0371-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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