Z-0296-2021 Class II Ongoing
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