Device product

LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

Z-0296-2021

September 17, 2020

Class II

Product summary

Firm: THREAD COUNSEL INC DBA LAWS OF MOTION
Event: Event 86431
Status: Ongoing
Classification: Class II
Quantity: 2.4 million
Official record key: device-enforcement:Z-0296-2021

Official wording

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

Code information: Lots 1 -47

Distribution pattern: Distributed to accounts in New York

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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