Recall Z-1044-2023 ยท MQL Media, Reproductive
CooperSurgical, Inc.
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
| Date | Jan 31, 2023 (initiated Dec 15, 2022) |
| Status | Open, Classified |
| Reason | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo. |
| Root cause | Labeling Change Control |
| Action | An "URGENT: VOLUNTARY MEDIA RECALL" letter dated 12/13/22 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 Return the Product to CooperSurgical through our Recall Return process. Credit will be applied to your account for reorder of correct product per our Recall process with no additional cost to you or your facilities. For CUSTOMERS: If you have the affected Pro |
| Quantity | 489 units |
| Distribution | Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Tur |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060983 | BIOPSY MEDIUM, MODEL REF 1062 Medicult A/S, Jul 28, 2006 |