34 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code LDQ·October 28, 2013
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·April 1, 2015
Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte
FDA Recall
Terminated
·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·October 31, 2018
MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code FPA·November 6, 2009
BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Enforcement
Class II
·Terminated·LDR Spine USA, Inc.·October 12, 2016
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Recall
Terminated
·LDR Spine USA, Inc.·Product code LXH·August 29, 2016
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FPA·February 19, 2015