Z-1348-2024 Class II Ongoing
FDA device recall Z-1348-2024 was initiated by Angiodynamics, Inc. on Jan 30, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 39 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Jan 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 units
Product Description
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
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 Pattern
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Code Information
UDI: 15051684023238 UPN: H965457811 Lot Number: 5791593 5794613 5797470
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1348-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026