GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
INVASIVE PROCEDURE TRAY MNS9510
Centurion Medical Products
Class I - Dangerous
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
Becton Dickinson & Company
Class I - Dangerous
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
IV SECUREMENT KIT IVS3405
Centurion Medical Products
Class I - Dangerous
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
IV START KIT IV8440
Centurion Medical Products
Class I - Dangerous
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Roche Diagnostics Operations
Class I - Dangerous
AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results
Class I - Dangerous
The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected.
IV KIT - SORBAVIEW IVS3475
Centurion Medical Products
Class I - Dangerous
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
Potential for leaking product
Potential for leaking product
Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).
Potential for leaking product
Potential for leaking product
Potential for leaking product
Potential for leaking product
Potential for leaking product
Potential for leaking product
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Class I - Dangerous
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.