BEUDAMED
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    Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code JIF·November 29, 2016

    DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·September 20, 2017

    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LDP·July 20, 2017

    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    FDA Enforcement
    Class II ·Terminated·Sekisui Diagnostics P.E.I. Inc.·February 1, 2017

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    FDA Enforcement
    Class II ·Terminated·Sekisui Diagnostics P.E.I. Inc.·March 23, 2016

    DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HRS·October 10, 2019

    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 16, 2016

    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 8, 2005

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code LDP·January 22, 2016

    Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.

    FDA Recall
    Terminated ·Product code HSB·April 2, 2009

    Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.

    FDA Recall
    Terminated ·Product code HSB·April 2, 2009

    Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.

    FDA Recall
    Terminated ·Product code HSB·April 2, 2009

    Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 070454 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.

    FDA Recall
    Terminated ·Product code HSB·April 2, 2009

    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 25, 2014

    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code 000·May 7, 2012

    Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FJK·December 10, 2007

    Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.

    FDA Recall
    Terminated ·Gambro Renal Products, Inc.·Product code FJK·May 2, 2008

    Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HJK·February 27, 2015

    Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010