23 results
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27ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010
Applied Medical's LAP CHOLE KIT 8 GK; Model Number: GK108 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010
Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
FDA Recall
Terminated
·GSK Consumer Healthcare·Product code N/A·April 25, 2016
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code GGK·December 19, 2007
BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT) Catalog # B36868
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code GGK·May 25, 2022
COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GGK·December 28, 2010
DiaSorin Analyte Specific Reagent
FDA Recall
Terminated
·Diasorin Inc.·Product code DGK·January 18, 2005
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code GGK·April 11, 2011
AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
FDA Recall
Terminated
·AGA Medical Corporation·Product code BGK·November 23, 2004
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code GGK·June 23, 2009
COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GGK·April 8, 2011
COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative determination of hemoglobin, enumeration of NRBC, and counting and sizing leukocytes on UniCel DxH 800 Coulter Cellular Analysis System.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GGK·July 11, 2011
ClubMax Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Logolas Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Burstberry Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Atom Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Spectrum Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code BRX·July 10, 2019
Maxim Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
VADER pedicle system, torque wrench, Catalog Number 42-703
FDA Recall
Open, Classified
·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023