FDAClass IIMarch 6, 2019

Cardiovascular Procedure Kit recall

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

Why was Cardiovascular Procedure Kit recalled?

Presence of natural rubber latex is not declared in the label

What should I do if I have this product?

Review the official FDA enforcement record for current 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 Numbers: V A30

Product
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Recalling firm
Terumo Cardiovascular Systems Corporation
Quantity
12 packs
Distribution
TX
Recall date
March 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls