Device recall
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
- Recall number
- Z-2930-2026
- Event id
- 99285
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Terumo Medical Corporation
- Report date
- Aug 19, 2026
- Initiated
- Jun 15, 2026
- Center classification date
- Aug 10, 2026
- Reason
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- Quantity
- 7,490 units
- Code info
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Elkton, MD, United States