FDAClass IIMarch 16, 2022

PuraSinus Absorbable Nasal Hemostat recall

PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006

Why was PuraSinus Absorbable Nasal Hemostat recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Recalling firm
3-D Matrix, Inc.
Quantity
3 units
Distribution
US Nationwide distribution in the state OH.
Recall date
March 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls