FDAClass IIAugust 24, 2022

Echelon -14 recall

Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only

Why was Echelon -14 recalled?

Outer carton packaging of microcatheters were exposed to wet substance during transport.

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?

Lot # B177543 UDI: (00) 847536006270

Product
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Recalling firm
Micro Therapeutics, Inc.
Quantity
8 units
Distribution
US Nationwide Distribution: None OUS: Brazil
Recall date
August 24, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls