FDAClass IIMarch 27, 2024

Mini Stick MAX 5f X 10 CM STD .018 Ni/tu Echo 2.75" PG recall

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

Why was Mini Stick MAX 5f X 10 CM STD .018 Ni/tu Echo 2.75" PG recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
Recalling firm
Angiodynamics, Inc.
Quantity
5176 units
Distribution
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Recall date
March 27, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls