Z-1577-2014 Class II Terminated
FDA device recall Z-1577-2014 was initiated by Nellcor Puritan Bennett Inc. (dba Covidien LP) on April 18, 2014 and is designated Class II. Reason for recall: Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally. The recall status is terminated (terminated March 1, 2016). Affected quantity: 5,765.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- April 18, 2014
- Termination Date
- March 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,765
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution -- USA, including the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Maryland, Missouri, Nevada, Pennsylvania, Rhode Island, Texas, Virginia, and Washington; and, the countries of Algeria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, England, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Japan, Kazakhstan, Kenya, Lebanon, Liechtenstein, Lithuania, Mexico, Morocco, Namibia, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Republic of Armenia, Republic of KOS, Russia, Saudi Arabia, Singapore, Slovenia, S. Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Vietnam, and Yemen.