Z-2067-2021 Class II Terminated
FDA device recall Z-2067-2021 was initiated by Mercedes Medical, Inc. on June 10, 2021 and is designated Class II. Reason for recall: No 510(k) clearance The recall status is terminated (terminated August 14, 2023). Affected quantity: SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs.
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- June 10, 2021
- Termination Date
- August 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. The country of Bahamas. Government distribution was made but no military distribution.