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    Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

    FDA Recall
    Open, Classified ·Fujifilm Irvine Scientific, Inc.·Product code MQL·January 16, 2023

    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

    FDA Recall
    Open, Classified ·Fujifilm Irvine Scientific, Inc.·Product code MQL·September 8, 2021

    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQL·August 25, 2016

    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-DCOS Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 9 x 1 mL Equilibration Solution- ES; 9 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

    FDA Recall
    Open, Classified ·Fujifilm Irvine Scientific, Inc.·Product code MQL·September 8, 2021

    LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQL·June 13, 2022

    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQL·February 16, 2024

    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQL·February 16, 2024

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

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQL·February 13, 2023

    BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQL·December 15, 2022

    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQL·August 25, 2016

    Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQL·February 16, 2024

    Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, Product Usage: Culture oil is intended to be used as an oil overlay for cultures of gametes, zygotes, or embryos in assisted reproductive technology (ART) and micro manipulation procedures. It is used to reduce the osmotic stress due to evaporation and to reduce pH fluctuations.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MQL·February 15, 2012

    MediCult Vitrification Cooling Media, Model Number 12284001F

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQL·September 8, 2020

    Sperm separation media are used to separate motile sperm from other constituents of semen.

    FDA Recall
    Open, Classified ·Fujifilm Irvine Scientific, Inc.·Product code MQL·November 2, 2023

    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code MQL·December 20, 2023

    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P

    FDA Recall
    Open, Classified ·WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany·Product code HIG·July 17, 2023

    Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

    FDA Recall
    Terminated ·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIG·August 14, 2019

    PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

    FDA Recall
    Open, Classified ·Nuvasive Specialized Orthopedics Inc·Product code HSB·February 12, 2021

    PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

    FDA Recall
    Open, Classified ·Nuvasive Specialized Orthopedics Inc·Product code HSB·February 12, 2021

    Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

    FDA Recall
    Open, Classified ·Nuvasive Specialized Orthopedics Inc·Product code HSB·February 12, 2021