FDAClass IIOctober 23, 2024

Medline Open Heart Pack recall

MEDLINE OPEN HEART PACK, REF DYNJ66216C

Why was Medline Open Heart Pack recalled?

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.

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?

UDI/DI 40193489853361 (case), 10193489853360 (each), Lot Numbers: 23LBM368, 23LBH354

Product
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
123 kits
Distribution
US Nationwide distribution.
Recall date
October 23, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls