Recall Z-1916-2023— Merit Medical Systems, Inc.

Name: FDA recall Z-1916-2023
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 Valve Repair Kit, REF: 4992306 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 Valve Repair Kit, REF: 4992306 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.