Terumo Medical Corporation GLIDESHEATH SLENDER A-KIT Recall (Unknown Month Year)
Announced 2026-08-19 · FDA
The Glidesheath Slender A-Kit 6F 10cm (.021GW) was packaged with a 0.025 guidewire instead of the intended 0.021 guidewire. About 7,490 units have been distributed worldwide, including the US and Canada. The recall is associated with Product Code 60-1060 and Lot Number 0001441871.
| 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 | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. |
| Severity | moderate |
| Units affected | 7490 |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Agency | FDA |
| Recall / campaign no. | Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871. |
WHAT YOU SHOULD DO
- Do not use any units from Lot 0001441871.
- Contact Terumo Medical Corporation for guidance on return or replacement of the affected Product Code 60-1060 units.
- If you have used the kit and experienced problems, report the issue to your healthcare provider and to the FDA MedWatch program.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.