Recall StatusOpen, Classified
Date Initiated2022-11-02
Product Quantity1606 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.
Firm 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
[email protected]
Root Cause
Packaging process control
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.