FDAClass IIOctober 21, 2020

MediCult Vitrification Cooling Media recall

MediCult Vitrification Cooling Media, Model Number 12284001F

Why was MediCult Vitrification Cooling Media recalled?

There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

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: 20230080

Product
MediCult Vitrification Cooling Media, Model Number 12284001F
Recalling firm
CooperSurgical, Inc.
Quantity
531 total boxes
Distribution
The products were distributed to China.
Recall date
October 21, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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