Z-0744-2022 Class II Terminated
FDA device recall Z-0744-2022 was initiated by 3-D Matrix, Inc. on December 2, 2019 and is designated Class II. Reason for recall: The boxes used by the shipper were not validated for use during transport. The recall status is terminated (terminated August 25, 2023). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- December 2, 2019
- Termination Date
- August 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
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 Pattern
US Nationwide distribution in the state OH.
Code Information
UDI: (01)00860001820829(17)220430(10)19E30A50; Lot Number 19E30A50