Z-0485-2025 Class II Ongoing
FDA device recall Z-0485-2025 was initiated by Maquet Cardiovascular, LLC on October 16, 2024 and is designated Class II. Reason for recall: Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. The recall status is ongoing. Affected quantity: 10,778 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2024
- Initiation Date
- October 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,778 units
Product Description
Reason for Recall
Distribution Pattern
Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.