Recall Z-0744-2022 ยท NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
3-D Matrix, Inc.
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
| Date | Dec 2, 2019 |
| Status | Terminated |
| Reason | The boxes used by the shipper were not validated for use during transport. |
| 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 Me |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the state OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183015 | PuraSinus 3-D Matrix, Inc., Apr 12, 2019 |