Z-0420-2024 Class I Ongoing
FDA device recall Z-0420-2024 was initiated by Maquet Medical Systems USA on October 10, 2023 and is designated Class I. Reason for recall: Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms a… The recall status is ongoing. Affected quantity: Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S..
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- October 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S.
Product Description
Reason for Recall
Distribution Pattern
US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Jordan, Mexico, New Zealand, Pakistan, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom