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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

Medical DevicesSource: FDA (device) · Date: 2026-08-19

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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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