Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Num
FDA device recall Z-1348-2023 · posted 2023-04-06 · Open, Classified
Recall details
- Recalling firm
- CooperSurgical, Inc.
- 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.
- Action taken
- 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 Recall@coopersurgical.com 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 Recall@coopersurgical.com. 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- MQL
- Quantity affected
- 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,
- Date initiated
- 2023-02-13
- Date posted
- 2023-04-06
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA (K142991) | Life Global Group, LLC | 2015-02-17 |