Angiodynamics, Inc. 2024-03-27 Health serious FDA
Health · FDA · Recall #FDA-Z-1335-2024
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous… Recall
Issued March 27, 2024 · Angiodynamics, Inc.
In March 2024, Angiodynamics, Inc. recalled the MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Angiodynamics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Angiodynamics, Inc.
- Category
- Health
- Recall date
- March 27, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
- Recall number
- FDA-Z-1335-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Angiodynamics, Inc. has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.