Recall Z-0070-2025— Merit Medical Systems, Inc.

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2024-08-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G. 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

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