MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" recall
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number…
Why was MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" 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: 15051684022934 UPN: H965457501 Lot Number: 5784035 5784036 5784136 5787837 5788554 5788555 5789978 5790448 5790449 5791589 5791590 5791591 5797460 5797461 5798838 5799613 5799623 5800399 5804390 5806116
- Product
- MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number…
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 4366 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)