FDA recall Z-0744-2022
3-D Matrix, Inc. · Class II · device
Product
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Reason for recall
The boxes used by the shipper were not validated for use during transport.
Distribution
US Nationwide distribution in the state OH.
Key facts
- Status
- Terminated
- Initiation date
- 2019-12-02
- Report date
- 2022-03-16
- Termination date
- 2023-08-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Newton, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2022