PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 recallZ-0744-2022 · 3-D Matrix, Inc. · initiated Dec 2, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3-D Matrix, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The boxes used by the shipper were not validated for use during transport.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0744-2022
- Status
- Terminated
- Initiated by the company
- Dec 2, 2019
- Recalling firm
- 3-D Matrix, Inc.
- Quantity
- 3 units
- Product code
- NHB
- FDA submissions
- K183015
- Distribution
- US Nationwide distribution in the state OH.
Product description
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Code information (models, lots, serial numbers)
UDI: (01)00860001820829(17)220430(10)19E30A50; Lot Number 19E30A50
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PuraSinus 5mL 651-0093-D Matrix Inc. · Polymer, Ear, Nose And Throat, Synthetic, Absorbable1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K183015 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- PuraSinus 3mL 651-0083-D Matrix Inc. · Polymer, Ear, Nose And Throat, Synthetic, Absorbable1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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