CooperSurgical recalls MediCult Vitrification Cooling Media Model 12284001F due to label printing error showing wrong product type. Affected units sold in 2023 with specific lot number.
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.
CooperSurgical is recalling MediCult Vitrification Cooling Media Model 12284001F because the product label shows it contains an Equilibration Medium instead of Vitrification Medium. This labeling error could lead to incorrect use in medical procedures.
The label shows Chinese characters indicating an Equilibration Medium (P/N: 12220001) instead of the Vitrification Medium (P/N: 12230001) as stated elsewhere. This discrepancy means the product might be used incorrectly in medical procedures, potentially causing improper freezing or thawing of tissues.
Users of this medical cooling media for procedures like cryotherapy are affected. Healthcare professionals using the product in clinical settings are most at risk due to potential misapplication.
Check for the model number 12284001F on the product packaging. The lot number 20230080 is associated with this specific recall batch.
Verify the model number and lot number on the packaging to confirm if it matches the recalled item.
The model number is 12284001F.
The lot number is 20230080.
The product label shows Chinese characters indicating it contains an Equilibration Medium instead of Vitrification Medium as stated elsewhere.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0100-2021 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0100-2021 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
