Recall Z-1736-2025— Galt Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Galt Medical Corporation, initiated 2025-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires. Reason: Due to a potential open seal in the sterile barrier packaging..
- Recalling firm
- Galt Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-27
- Firm location
- Garland, TX, United States
Product description
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Reason for recall
Due to a potential open seal in the sterile barrier packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.