393 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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BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JQP·March 9, 2022
ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine
FDA Enforcement
Class II
·Terminated·Mckesson Medical-Surgical Inc. Corporate Office·July 28, 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
Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.
FDA Recall
Terminated
·Theken Spine LLC·Product code KNW·August 27, 2008
BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: -Accessing pre-slit/pre-pierced IV septum ports -Providing for fluid transfer -Can be used as tubing adapter 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·February 11, 2015
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
FDA Recall
Terminated
·CareFusion 303, Inc.·Product code CCK·July 1, 2019
BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: -Accessing pre-slit/pre-pierced IV septum ports -Providing for fluid transfer -Can be used as tubing adapter 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FMF·December 19, 2014
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
FDA Recall
Terminated
·Becton Dickinson & Company·Product code NGT·April 16, 2020
BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276
FDA Recall
Terminated
·Becton Dickinson & Company·Product code LJS·February 26, 2020
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A
FDA Recall
Terminated
·Becton Dickinson & Company·Product code LJS·February 26, 2020
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
FDA Recall
Terminated
·Becton Dickinson & Company·Product code LJS·February 26, 2020
BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
FDA Recall
Terminated
·Becton Dickinson & Company·Product code LJS·February 26, 2020
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025
FDA Recall
Terminated
·Becton Dickinson & Company·Product code LJS·February 26, 2020
BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B
FDA Recall
Terminated
·Becton Dickinson & Company·Product code LJS·February 26, 2020
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
FDA Recall
Terminated
·Becton Dickinson & Company·Product code LJS·February 26, 2020
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
FDA Recall
Terminated
·Becton Dickinson & Company·Product code LJS·February 26, 2020
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
BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FMF·May 25, 2017