Z-0296-2021 Class II Ongoing
FDA device recall Z-0296-2021 was initiated by THREAD COUNSEL INC DBA LAWS OF MOTION on September 17, 2020 and is designated Class II. Reason for recall: Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns. The recall status is ongoing. Affected quantity: 2.4 million.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- September 17, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2.4 million
Product Description
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
Reason for Recall
Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.
Distribution Pattern
Distributed to accounts in New York
Code Information
Lots 1 -47