Class I Medical Device Recall: Respironics, Inc., Trilogy 100, 200, and 202 Ventilators
Recall Class: Class I
Date Recall Initiated: April 27, 2012
Products: Trilogy 100, 200, and 202 Ventilators
Model/Catalog Numbers: 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.
These ventilators were manufactured from January 1, 2012 through April 27, 2012 and distributed from March 1, 2012 through May 1, 2012.
Use: The Trilogy 100, 200, and 202 ventilators are intended for continuous or intermittent breathing support for patient populations ranging from pediatric patients, weighing at least 11 pounds, to adult patients. The ventilators are used in hospitals, nursing homes, other health care settings, and in the home.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517
Reason for Recall: The Trilogy 100, 200, and 202 ventilators are being recalled because power supply components may be defective in some cases. If a ventilator’s power supply fails, the ventilator may unexpectedly stop functioning, thereby stopping ventilation. The ventilator alarm may also fail to sound. Ventilator power supply failures can result in serious adverse health consequences, including death.
Public Contact: Affected customers may contact Respironics Customer Service at 1-877-387-3311.
FDA District: Philadelphia District Office
On Friday, April 27, 2012, Respironics, Inc. began contacting their affected U.S. customers by phone. The firm requested customers to quarantine any affected devices within their possession and to retrieve any devices with patients and quarantine those as well. The company will provide replacement devices to all affected customers. In the time period prior to Respironics replacing the device, the patient’s health care providers should provide an alternative device.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.