Summary
The FDA issued a Class II for PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 by 3-D Matrix, Inc.. Reason: The boxes used by the shipper were not validated for use during transport..
Details
Source
Device Recall
External ID
Z-0744-2022
Action Date
2022-03-16
Status
Terminated
Category
device
Product Description
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Lot/Code Info: UDI: (01)00860001820829(17)220430(10)19E30A50; Lot Number 19E30A50
Quantity Affected: 3 units
Reason for Recall
The boxes used by the shipper were not validated for use during transport.
Distribution
US Nationwide distribution in the state OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2019-12-02
Company
Newton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3-D Matrix, Inc. has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (3-D Matrix, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3-D Matrix, Inc. have FDA actions?
3-D Matrix, Inc. has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0744-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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