Recall Z-1348-2023— CooperSurgical, Inc.

Name: FDA recall Z-1348-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-13

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2023-02-13. It names one FDA 510(k) clearance: K142991. Product: Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060. Reason: 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-13
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K142991 — LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSALife Global Group, LLC·cleared 2015-02-17

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

Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

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.

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