Z-0100-2021Class II

MediCult Vitrification Cooling Media, Model Number 12284001F

Name: Z-0100-2021 MediCult Vitrification Cooling Media, Model Number 12284001F
Creator: CooperSurgical, Inc.
Published: 2020-09-08
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2020-09-08 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of MediCult Vitrification Cooling Media, Model Number 12284001F on 2020-09-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0100-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-08
Posted: 2020-10-13
Terminated: 2021-01-11
Recalling firm: CooperSurgical, Inc.
Product: MediCult Vitrification Cooling Media, Model Number 12284001F
Product code: MQL Media, Reproductive
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE letters dated 9/8/20 were sent to customers. Our records indicate that you have purchased the affected Product from CooperSurgical. The affected Vitrification Medium Product is of the correct formulation and functionally acceptable per quality release specifications and will work as intended in accordance with the accompanying Instructions For Use. Please discontinue use of and quarantine the Products, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Field Safety Notice. The Chinese Food and Drug Administration has been notified of this Field Safety Notice. We sincerely apologize for any inconvenience caused by this Field Safety Notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at +001.203.601.5200 ext. 3300.
Quantity in commerce: 531 total boxes
Distribution: The products were distributed to China.
Product codes and lots: Lot: 20230080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0100-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0100-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-13

Product code MQL

K100367Class IIMedicult Vitrification Cooling/warming, Model Ref: 1228, 1229Origio A/S / cleared 2010-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)