Recall Z-0071-2025— Merit Medical Systems, Inc.
Class II · Ongoing
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: basixSKY Inflation Device, REF: SKY1802. 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
Product description
basixSKY Inflation Device, REF: SKY1802
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.