Angiodynamics, Inc.: MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754

Hazard

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

Details from the source

Reason for recall: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case Distribution: Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA. Quantity: 1676 units Lot/code info: UDI: 15051684022972 UPN: H965457541 Lot Number: Lot: 5784134 5787807 5787808 5787809 5787810 5789980 5790676 5800402 5803531

UPC codes

15051684022972

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.