FDA-Device2020-11-04Class II

LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

THREAD COUNSEL INC DBA LAWS OF MOTION
Hazard

Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.

Sold states
Distributed to accounts in New York
Affected count
2.4 million
Manufactured in
175 Varick St, N/A, New York, NY, United States
Products
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0296-2021

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