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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Affected units
- 3
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
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