FDA recall Z-1071-2022

Microtek Medical Inc. · Class II · device

Product

TMJ Arthroscopy Drape, 85''x 96''

Reason for recall

Latex content in product was labeled incorrectly as latex free.

Distribution

Distributed nationwide to CO, PA, and WI.

Key facts

Status
Terminated
Initiation date
2022-04-08
Report date
2022-05-18
Termination date
2024-06-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1071-2022