The Recall Desk
ModerateFDA (Devices)·Z-0744-2022·Announced 2022-03-16

PuraSinus Nasal Hemostat Recalled Due to Unvalidated Shipping Boxes

3-D Matrix, Inc. is recalling PuraSinus Absorbable Nasal Hemostat units because the shipping boxes used for transport were not validated.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a packaging and transport validation issue with no reported illnesses, injuries, or deaths. The recall is precautionary based on unvalidated shipping containers for a Class II medical device.

Plain-English summary

3-D Matrix, Inc. is recalling the PuraSinus Absorbable Nasal Hemostat (Part Numbers 651-006, Lot Number 19E30A50). The recall is issued because the boxes used by the shipper to transport these devices were not validated for use during transport.

This recall affects 3 units that were distributed in Ohio. Consumers and healthcare providers who have received the affected product should contact 3-D Matrix, Inc. for further instructions.

The recalled product

Product
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Manufacturer
3-D Matrix, Inc.
Category
Medical Device — Nasal Hemostatic
Hazard
  • packaging-defect
  • transport-damage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI: (01)00860001820829(17)220430(10)19E30A50
  • Lot Number 19E30A50

Distribution

Distributed nationwide across the United States.

Related recalls

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