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U.S. Department of Health and Human Services

Class 2 Device Recall PuraSINUS Gel

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  Class 2 Device Recall PuraSINUS Gel see related information
Date Initiated by Firm December 02, 2019
Create Date March 10, 2022
Recall Status1 Terminated 3 on August 25, 2023
Recall Number Z-0744-2022
Recall Event ID 89577
510(K)Number K183015  
Product Classification Polymer, ear, nose and throat, synthetic, absorbable - Product Code NHB
Product PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Code Information UDI: (01)00860001820829(17)220430(10)19E30A50; Lot Number 19E30A50
Recalling Firm/
Manufacturer		 3-D Matrix, Inc.
1234 Chestnut St Ste 205
Newton MA 02464-1451
For Additional Information Contact Brian Dixon
781-373-9034
Manufacturer Reason
for Recall		 The boxes used by the shipper were not validated for use during transport.
FDA Determined
Cause 2		 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 infous@puramatrix.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NHB and Original Applicant = 3-D Matrix, Inc.
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