BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage emb...
FDA Recall #Z-1044-2023 — Class II — December 15, 2022
Product Description
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
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.
Recalling Firm
CooperSurgical, Inc. — Trumbull, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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, Turkmenistan, and United Arab Emirates.
Code Information
Lot Number: 220506-006557
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated