PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Recall
- Recall Number
- Z-0744-2022
- Event Number
- 89577
- Firm
- 3-D Matrix, Inc.
- FEI Number
- 3015528146
- Product Code
- NHB
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- December 2, 2019
- Terminated
- August 25, 2023
- Address
- 1234 Chestnut St, Ste 205, Newton, MA, 02464-1451
Description
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
The boxes used by the shipper were not validated for use during transport.
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.
US Nationwide distribution in the state OH.
3 units