Terumo Glidesheath Slender kit recalled for wrong guidewire packaged
Terumo Medical Corporation is recalling certain GlideSheath Slender A-Kit 6F 10cm .021GW kits (Product Code 60-1060) because they were packaged with a 0.025 guidewire instead of the labeled 0.021 guidewire. The kit is used to help place a catheter through the skin into the radial artery. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check the lot number on the pouch or shelf box. The affected lot is 0001441871.
- Stop using kits from the affected lot and separate them from inventory.
- Follow your facility's recall procedures and contact Terumo Medical Corporation for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 7,490 units
- Illnesses reported
- None reported
- Manufactured in
- 950 Elkton Blvd, Elkton, MD, United States
- Classification
- Class II
- Recall number
- Z-2930-2026
In the FDA's words
- Description
- 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. Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Affected quantity: 7,490 units
- Hazard
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.