FDAClass IINovember 8, 2023

AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 recall

AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

Why was AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 recalled?

Peripheral coil system detachable has a potential of unsealed pouch packaging.

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-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027

Product
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Recalling firm
MICROVENTION INC.
Quantity
14
Distribution
US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Recall date
November 8, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls