Home / Recalls / Mercedes Medical, Inc. / Z-2067-2021

Z-2067-2021 Class II Terminated

Recalled by Mercedes Medical, Inc. — Lakewood Ranch, FL

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

Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

Reason for Recall

No 510(k) clearance

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.

Code Information

All lots.