Z-2596-2021 Class II Ongoing
FDA device recall Z-2596-2021 was initiated by GE Healthcare, LLC on August 2, 2021 and is designated Class II. Reason for recall: The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to ov… The recall status is ongoing. Affected quantity: Estimated 310,072 flow sensors.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- August 2, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Estimated 310,072 flow sensors
Product Description
Reason for Recall
Distribution Pattern
Distribution was nationwide, including PR. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Madagascar, Malaysia, Maldives, Mali, Malta, Mauritius, Mexico, Moldova, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom Uruguay, Venezuela, Vietnam, and Yemen.