Z-0744-2022Class II

PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006

Name: Z-0744-2022 PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Creator: 3-D Matrix, Inc.
Published: 2019-12-02
License: https://open.fda.gov/license/

3-D Matrix, Inc. / initiated 2019-12-02 / Terminated / root cause: packaging

FDA source

3-D Matrix, Inc. began a recall of PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 on 2019-12-02. FDA classified it as Class II and gives the reason as "The boxes used by the shipper were not validated for use during transport". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0744-2022
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Posted: 2022-03-10
Terminated: 2023-08-25
Recalling firm: 3-D Matrix, Inc.
Product: PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Product code: NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Reason for recall: The boxes used by the shipper were not validated for use during transport.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: A notification letter dated 12/2/19 was sent to the customer. The purpose of this letter is to inform you of the market withdrawal of 3 units of PuraSinus peptide hydrogel, lot#: 19E30A50, Expiration April 2022 (UDI #: (0l)00860001820829(17)220430(10)19E30A50) shipped to your location on October 7, 2019. The reason for this market withdrawal is that the boxes used by the shipper located in Florida are boxes that are designed to maintain proper temperatures during transport, however the boxes that were used are not the boxes that we have validated for use during transport. While 3-D Matrix Medical Technology is reasonably certain that the product was not damaged or degraded in any way - because upon arrival the contents of the package were observed to still be cool and our internal testing has demonstrated product stability over a much wider range of temperatures (product is stable from -5 C to 30 C) than our specified shipping temperatures in transit to your office, in an abundance of caution we are requesting the market withdrawal of the product from consideration for use in your patients immediately and encourage you to return the three units of PuraSinus to the manufacturer at your earliest convenience. 3-D Matrix Inc. will provide shipping instructions and a prepaid label for your use in facilitating the return in the coming days. We apologize for this inconvenience and if acceptable, 3-D Matrix, Inc. will ship replacement products in the proper shipping containers Please contact 3-D Matrix, Inc. with any questions at [email protected] or 1-781-373-9020. As a trusted partner in healthcare, we are committed to your patient's safety.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the state OH.
Product codes and lots: UDI: (01)00860001820829(17)220430(10)19E30A50; Lot Number 19E30A50

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0744-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0744-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-10

Product code NHB

K183015Class IIPuraSinus3-D Matrix, Inc. / cleared 2019-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)