Z-2446-2024 Class I Ongoing
FDA device recall Z-2446-2024 was initiated by Covidien on June 24, 2024 and is designated Class I. Reason for recall: Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devi… The recall status is ongoing. Affected quantity: 34,642.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- June 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,642
Product Description
Reason for Recall
Distribution Pattern
US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR, TX, WI, PA, CO, MI, NM, RI, VA, DC, VT, NC, NH, WV, NV, IA. OUS: Argentina, Australia, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Montenegro, Namibia, Nepal, New Zealand, Nigeria, Panama, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Viet Nam, South Africa, Austria, Kenya, Latvia, Lebanon, Mongolia, Nicaragua, Thailand, Tunisia, Algeria, Jordan, Libya, Malawi, Qatar, Pakistan, United Arab Emirates, Oman, Peru, Philippines, Bhutan, Iran - Islamic Republic Of, Bolivia, Kuwait, Egypt, Switzerland, Sudan, Norway, Korea - Republic Of, Bahrain, Ethiopia, Paraguay