Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LifePort Endotracheal Tube Adapters

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall LifePort Endotracheal Tube Adapters see related information
Date Initiated by Firm November 02, 2022
Date Posted December 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-0371-2023
Recall Event ID 91103
PMA Number P850064S035 
Product Classification Ventilator, high frequency - Product Code LSZ
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
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
Recalling Firm/
Manufacturer		 Bunnell, Inc.
436 W Lawndale Dr
Salt Lake City UT 84115-2917
For Additional Information Contact
801-467-0800
Manufacturer 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.
FDA Determined
Cause 2		 Packaging process control
Action 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
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LSZ and Original Applicant = BUNNELL, INC.
-
-