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Sources: EU EUDAMED, US FDA
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Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Medtronic MiniMed paradigm mio Infusion Sets MMT-921 The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum.
FDA Recall
Terminated
·Medtronic Minimed·Product code FPA·May 16, 2011
Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits are intended for use in refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps
FDA Recall
Terminated
·Medtronic, Inc. Neuromodulation·Product code LKK·January 14, 2011
Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.
FDA Recall
Terminated
·Medtronic, Inc. Neuromodulation·Product code LKK·January 14, 2011
Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: " Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain Preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of preservative-free morphine sulfate sterile solution. " Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain Preservative-free sterile saline, USP, can only be used to achieve the physician prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. " Chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen injection). " Chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency.
FDA Recall
Terminated
·Medtronic, Inc. Neuromodulation·Product code LKK·January 14, 2011
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.
FDA Enforcement
Class II
·Terminated·TZ Medical Inc.·November 25, 2015
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
FDA Recall
Terminated
·Sunstar Americas, Inc.·Product code NTO·May 21, 2021
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
FDA Enforcement
Class II
·Terminated·Sunstar Americas, Inc.·June 16, 2021
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·January 10, 2018
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DYB·December 10, 2020
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.
FDA Enforcement
Class II
·Terminated·Anika Therapeutics, Inc.·July 18, 2018
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code ELW·February 4, 2013
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code ELW·February 4, 2013
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
FDA Recall
Terminated
·Clinician's Choice Dental Products Inc.·Product code ELW·March 18, 2022