FDAClass IIMay 17, 2023

Cobra-os recall

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

Why was Cobra-os recalled?

Custom sheath Introducer contains incorrect needle size

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 # H2122096S1; UDI-DI: (00)884450525197

Product
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Recalling firm
Merit Medical Systems, Inc.
Quantity
1186 units
Distribution
US Distribution to state of: Minnesota
Recall date
May 17, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls