Home/Recalls/FDA-Z-2930-2026
FDA DevicesClass II

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.

Published: August 19, 2026Recall ID: Z-2930-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

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.

Recalling Firm: Terumo Medical Corporation

Reason for Recall / Hazard

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

Product Description & Identification

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.

Affected Products

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.

Additional Source Details

FieldValue
CityElkton
StateMD
Event id99285
Address 1950 Elkton Blvd
Code infoProduct Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
Postal code21921-5322
Report date20260819
Product typeDevices
Product quantity7,490 units
Reason for recallProduct was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260615
Initial firm notificationTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date20260810

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Overview

  • Recalling FirmTerumo Medical Corporation
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide distribution - US Nationwide and the country of Canada.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: 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 catheter through the skin into the radial artery.

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