July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Nu
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, M
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DY
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Mod
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF,
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH,
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Mo
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number D
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ8
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use dur
Hazard: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
July 26, 2023Medical DevicesFDA
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 bo
Hazard: There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
July 26, 2023Medical DevicesFDA
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Hazard: An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
July 26, 2023Medical DevicesFDA
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0
Hazard: An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
July 26, 2023Medical DevicesFDA
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Hazard: IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
July 26, 2023Medical DevicesFDA
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0
Hazard: IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
July 26, 2023Medical DevicesFDA
Bryan Medical Inc recalls Aeris Balloon Dilation Catheter
Hazard: Devices were mislabeled.
July 26, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Hazard: Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
July 26, 2023Medical DevicesFDA
Aesculap Implant Systems LLC recalls Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Hazard: Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
July 26, 2023Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Hazard: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
July 26, 2023Medical DevicesFDA
Beckman Coulter Biomedical GmbH recalls Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Hazard: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
July 26, 2023Medical DevicesFDA
Abiomed, Inc. recalls Impella LD intravascular micro axial blood pump, Product Number 005082
Hazard: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.