Terumo Medical Corporation: GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Terumo Medical Corporation
- Product
- 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.
- Reason / hazard
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall initiated
- 2026-06-15
- Code info
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- Product quantity
- 7,490 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Elkton
- State
- MD
- Country
- United States
- Event id
- 99285
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