Z-0633-2021 Class II Terminated
FDA device recall Z-0633-2021 was initiated by Maquet Cardiovascular Us Sales, Llc on November 20, 2020 and is designated Class II. Reason for recall: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier. The recall status is terminated (terminated November 7, 2024). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- November 20, 2020
- Termination Date
- November 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.