Z-1348-2023Class II

Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer...

Name: Z-1348-2023 Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer...
Creator: CooperSurgical, Inc.
Published: 2023-02-13
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2023-02-13 / Open, Classified / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 on 2023-02-13. FDA classified it as Class II and gives the reason as "It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1348-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-13
Posted: 2023-04-06
Recalling firm: CooperSurgical, Inc.
Product: Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Product code: MQL Media, Reproductive
Reason for recall: It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: An URGENT: VOLUNTARY MEDIA RECALL dated 1/26/23 was sent to customers. Actions to be Taken: For both CUSTOMERS and DISTRIBUTORS: " Inspect your stock for the Product from this lot. Lot information can be found on the box and bottle labeling. o If found, quarantine, and discontinue use of the Product from this lot immediately. o Please complete and return the appropriate enclosed Acknowledgment Form (even if you do not have the specific lot remaining in stock) to initiate our recall return process. Credit will be applied to your account to reorder replacement product, as per our recall process, with no additional cost to you or your facilities. o The form can be returned to CooperSurgical via email at [email protected] or via fax at +1.203.601.9870 Please feel free to contact your local account manager or contact us at +1-203-601-5200 Monday Friday 09:00 17:00 EST, and follow the phone prompt to enter the ext. 3300 or via email at [email protected]. If affected Product has been distributed to customers, please select one of the following options: " I have identified and notified all customers to whom the affected Product may have been distributed. " I am providing a list of all customers to whom affected Product may have been distributed along with their contact information.
Quantity in commerce: 190 units
Distribution: Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.
Product codes and lots: UDI-DI: 00815965020433; LOT 221118-010694

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1348-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1348-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-06

Product code MQL

K142991Class IILifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSALife Global Group, LLC / cleared 2015-02-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)