FDA recall Z-2930-2026

Terumo Medical Corporation · Class II · device

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 for recall

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

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2026-06-15
Report date
2026-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elkton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2930-2026