Z-1335-2023 Class II Ongoing
FDA device recall Z-1335-2023 was initiated by Maquet Cardiovascular, LLC on March 6, 2023 and is designated Class II. Reason for recall: Some batches of product were not sterilized to their minimum sterilization specification. The recall status is ongoing. Affected quantity: 900 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2023
- Initiation Date
- March 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 units
Product Description
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Reason for Recall
Some batches of product were not sterilized to their minimum sterilization specification.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Brazil, China.
Code Information
UDI-DI: 00607567701250; Lot Numbers: 3000280189, 3000276183