FDAClass IIJanuary 13, 2021

Cardiac Pack - LF recall

Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and…

Why was Cardiac Pack - LF recalled?

The cylindrical sponge component is not x-ray detectable.

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 20GBG768 (Expiration: 11/30/2021); 20HBO067 (Expiration: 02/28/2022); Lot 20IBC642 (Expiration 03/31/2022)

Product
Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and…
Recalling firm
Medline Industries Inc
Quantity
360
Distribution
Foreign distribution only - Canada.
Recall date
January 13, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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