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Device Class II · moderate Ongoing

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.

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Recalling firmTerumo Medical Corporation
ReasonProduct was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateAug 19, 2026
InitiatedJun 15, 2026
RegionMD, United States
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Quantity7,490 units
Code/LotProduct Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
TypeVoluntary: Firm initiated
Recall numberZ-2930-2026

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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openFDA (U.S. Food & Drug Administration) — food/drug/device enforcement · CC0 1.0 (public domain)

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