Recall Z-1914-2023— Merit Medical Systems, Inc.

Name: FDA recall Z-1914-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-22

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2023-04-22. It names 2 FDA 510(k) clearances: K212675, K110396. Product: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only. Reason: There is a potential that valve assemblies will not open. preventing fluid from draining..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-22
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

2 on FDA's record

K212675 — Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.·cleared 2021-12-14
K110396 — ASPIRA PERITONEAL DRAINAGE SYSTEMC.R. Bard, Inc.·cleared 2011-05-06

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

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

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