19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure.
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code LXH·November 26, 2018
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
FDA Recall
Terminated
·TITAN SPINE, LLC·Product code OVE·February 20, 2015
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JQP·March 9, 2022
12C
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·June 20, 2018
Proteus ONE and Proteus Plus
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·June 20, 2018
12C
FDA Recall
Terminated
·Product code LHN·September 16, 2016
Proteus ONE and Proteus Plus
FDA Recall
Terminated
·Product code LHN·September 16, 2016
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
FDA Recall
Terminated
·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code JQP·August 24, 2018
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
FDA Recall
Terminated
·CareFusion 303, Inc.·Product code CCK·July 1, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code QJR·March 24, 2021
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code LJT·March 25, 2021
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code LJT·March 25, 2021
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code LJT·March 25, 2021
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E Infusion sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FPA·May 6, 2019
BD Beaver Slit Blade 3.0mm Straight Part Number: 375521 The BD Beaver Slit Blade is used to perform the main incision through which instruments are inserted during cataract surgery.
FDA Recall
Terminated
·Bd Medical Systems·June 24, 2010
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
FDA Recall
Terminated
·Product code FPA·April 9, 2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
FDA Recall
Terminated
·Product code FPA·April 9, 2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
FDA Recall
Terminated
·Product code FPA·April 9, 2020
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
FDA Recall
Terminated
·Laerdal Medical (Suzhou) Co., Ltd. Science & Technology Ind. Park No.·Product code JCX·December 18, 2020