FDA Device recall Z-1339-2024
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756 by Angiodynamics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1339-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-30 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Angiodynamics |
| Distribution | US |
Product
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
Reason
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
Identifiers
| code_info | UDI: 15051684022996 UPN: H965457561 Lot Number: 5796084 5796085 5796086 5796087 5796088 5796089 57960…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1339-2024%22
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