BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
- Company
- Coopersurgical, Inc.
- Recall Initiated
- December 15, 2022
- Posted
- January 31, 2023
- Recall Number
- Z-1044-2023
- Quantity
- 489 units
- Firm Location
- Trumbull, CT
Reason for Recall
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.
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, Turkmenistan, and United Arab Emirates.
Lot / Code Info
Lot Number: 220506-006557
Root Cause
Labeling Change Control
Action Taken
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 Product, contact CooperSurgical at Recall@coopersurgical.com. Or call +1-203-601-5200 and follow the phone prompt to enter the ext. 3300. If you received this letter (even if you do not have the specific lot remaining in stock), please complete and return the enclosed Customer Acknowledgement Form to Recall@coopersurgical.com. For DISTRIBUTORS: If the Product has been distributed to your customers, send this letter (including the Customer Acknowledgement Form) to your customers. Complete and return the enclosed Distributor Acknowledgement and Receipt Form to Recall@coopersurgical.com. Please feel free to reach us at +1-203-601-5200 and follow the phone prompt to enter the ext. 3300 or via email at Recall@coopersurgical.com.