Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI
Summary
The FDA issued a Class II for Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containin by Mercedes Medical, Inc.. Reason: No 510(k) clearance.
Details
Source
Device Recall
External ID
Z-2067-2021
Action Date
2021-07-21
Status
Terminated
Category
device
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.
Lot/Code Info: All lots.
Quantity Affected: SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs
Reason for Recall
No 510(k) clearance
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-10
Company
Lakewood Ranch, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mercedes Medical, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mercedes Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mercedes Medical, Inc. have FDA actions?
Mercedes Medical, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2067-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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