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Recall Observatory FDA recall evidence

Device product

PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006

Z-0744-2022

December 02, 2019

Class II

Product summary

Firm
3-D Matrix, Inc.
Event
Event 89577
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0744-2022

Official wording

Reason: The boxes used by the shipper were not validated for use during transport.

Code information: UDI: (01)00860001820829(17)220430(10)19E30A50; Lot Number 19E30A50

Distribution pattern: US Nationwide distribution in the state OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The boxes used by the shipper were not validated for use during transport.