Recall Z-2067-2021— Mercedes Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Mercedes Medical, Inc., initiated 2021-06-10, terminated 2023-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: No 510(k) clearance.
- Recalling firm
- Mercedes Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-10
- Terminated
- 2023-08-14
- Firm location
- Lakewood Ranch, FL, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.