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.
- 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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