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.
Terumo Medical Corporation
The hazard
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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 identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975Model Pouch UDI-DI: 00389701011974Model UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.UPC 30389701011975UPC 00389701011974Would you have heard about this one?
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