MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction...
FDA Recall #Z-1344-2024 — Class II — January 30, 2024
Product Description
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
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
Recalling Firm
Angiodynamics, Inc. — Queensbury, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
200 units
Distribution
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Code Information
UDI: 15051684023108 UPN: H965457671 Lot Number: 5787806 5790679 5795962 5803521 5806728
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.