FDAClass IIJanuary 29, 2025

DLP Pediatric One-Piece Arterial Cannulae recall: Labeling Error

DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

Why was DLP Pediatric One-Piece Arterial Cannulae recalled?

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

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?

Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097

Product
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Recalling firm
Medtronic Perfusion Systems
Quantity
745 units
Distribution
Worldwide - US Nationwide distribution.
Recall date
January 29, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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