Recall Z-1044-2023— CooperSurgical, Inc.

Name: FDA recall Z-1044-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2022-12-15. It names one FDA 510(k) clearance: K060983. Product: BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD). 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-15
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K060983 — BIOPSY MEDIUM, MODEL REF 1062Medicult A/S·cleared 2006-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.