Recall Z-0744-2022— 3-D Matrix, Inc.

Name: FDA recall Z-0744-2022
Creator: U.S. Food and Drug Administration
Published: 2019-12-02

Class II · Terminated

Class II FDA medical device recall by 3-D Matrix, Inc., initiated 2019-12-02, terminated 2023-08-25. It names one FDA 510(k) clearance: K183015. Product: PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006. Reason: The boxes used by the shipper were not validated for use during transport..

Recalling firm: 3-D Matrix, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Terminated: 2023-08-25
Firm location: Newton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183015 — PuraSinus3-D Matrix, Inc.·cleared 2019-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006

Reason for recall

The boxes used by the shipper were not validated for use during transport.

Data sourced from openFDA. This site is unofficial and independent of the FDA.