Recall Z-0064-2025— Merit Medical Systems, Inc.

Name: FDA recall Z-0064-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-19

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2024-08-19. It names one FDA 510(k) clearance: K083523. Product: Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C. Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-19
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K083523 — MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGEMerit Medical Systems, Inc.·cleared 2009-02-04

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

Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

Reason for recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

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