| Class 2 Device Recall LifePort Endotracheal Tube Adapters | |
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
|
|
|
|