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Recall Observatory FDA recall evidence

Device product

MediCult Vitrification Cooling Media, Model Number 12284001F

Z-0100-2021

September 08, 2020

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 86479
Status
Terminated
Classification
Class II
Quantity
531 total boxes
Official record key
device-enforcement:Z-0100-2021

Official wording

Reason: 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.

Code information: Lot: 20230080

Distribution pattern: The products were distributed to China.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.