Angiodynamics, Inc.: MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756

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: 5176 units Lot/code info: UDI: 15051684022996 UPN: H965457561 Lot Number: 5796084 5796085 5796086 5796087 5796088 5796089 5796090 5796659 5796660 5796661 5796662 5796663 5796666 5797456 5797465 5798836 5798841 5798842 5799620 5800404 5803526 5804396

UPC codes

15051684022996

Source

Official record: FDA (Device enforcement) ↗

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