FDAFDA · Food and drugs·Recall number Z-1348-2024
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
Published March 27, 2024 · Recall initiated: January 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
- Lot
- UDI: 15051684023238 UPN: H965457811 Lot Number: 5791593 5794613 5797470
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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