FDAClass IIApril 27, 2022

Cardiovascular Procedure Kit recall

Cardiovascular Procedure Kit catalog # 76645 & 73806

Why was Cardiovascular Procedure Kit recalled?

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

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 #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]

Product
Cardiovascular Procedure Kit catalog # 76645 & 73806
Recalling firm
Terumo Cardiovascular Systems Corp
Quantity
64
Distribution
US Nationwide distribution in the states of CA and IN.
Recall date
April 27, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls