Recall Z-1939-2020— Remel Inc.

Name: FDA recall Z-1939-2020
Creator: U.S. Food and Drug Administration
Published: 2019-01-04

Class II · Terminated

Class II FDA medical device recall by Remel Inc., initiated 2019-01-04, terminated 2020-08-17. FDA's recall record names no specific 510(k) clearance for this event. Product: SWIN 2017 database, Model YSW4000. Reason: Potential for out of range microbial results.

Recalling firm: Remel Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Terminated: 2020-08-17
Firm location: Oakwood Village, OH, United States

Product description

SWIN 2017 database, Model YSW4000

Reason for recall

Potential for out of range microbial results

Data sourced from openFDA. This site is unofficial and independent of the FDA.