All recalls8,501 total
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Certain lots of product have the potential for a sterile barrier breach.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Potential contamination with Salmonella.
Potential contamination with Salmonella.
Contains undeclared allergens (cashews, milk, and soy).
Foreign object found inside retail container.
Potential contamination with Salmonella.
Chemical contamination; presence of lead and lithium above specification
Lack of Assurance of Sterility
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Lack of Assurance of Sterility
Contains undeclared FD&C Yellow 6
Foreign Material (plastic)
Labeling: Missing Label
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.
Undeclared Yellow #5
Undeclared Milk, Soy, Red #40.
Undeclared Milk, Red #40.
Undeclared Soy (with mitigating circumstances)
Undeclared Milk, Wheat, Soy, Yellow #5, Green #3.
Undeclared Milk, Walnuts, Eggs, Wheat, Soy.
Undeclared Red #40, Blue #1, Blue #2
Undeclared Milk, Eggs, Yellow #5.
Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.
Undeclared Red #40
Undeclared Milk, Almonds, Soy, Sulfites.
Undeclared Milk.
Undeclared Milk, Peanuts.
Undeclared Milk, Yellow #5.
Undeclared Milk, Pistachios, Yellow #5, Blue #1.
Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1
Undeclared Milk, Pecans.
Undeclared Milk, Eggs, Yellow #5.
Undeclared Milk, Walnuts, Eggs.
Undeclared Milk, Soy.
Undeclared Milk, Yellow #5.
Undeclared Milk, Yellow #6.
Undeclared Milk, Soy, Sulfites.