FDAClass IIMay 22, 2024

Medtronic Disposable Pressure Display Sets: a) DLP¿ recall

Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000

Why was Medtronic Disposable Pressure Display Sets: a) DLP¿ recalled?

Potential for unsealed sterile packing.

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?

a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225

Product
Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
Recalling firm
Medtronic Perfusion Systems
Quantity
1624 units
Distribution
Worldwide distribution.
Recall date
May 22, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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