Recall archive
Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.
Improperly eviscerated which may result in Clostridium botulinum contamination
Missing from associated official evidence: action.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Missing from associated official evidence: action.
Undeclared colors (FD&C Yellow 5 and FD&C Red 40).
Missing from associated official evidence: action.
CGMP Deviations
Missing from associated official evidence: action.
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open th...
Missing from associated official evidence: action, consumer scope.
Presence of foreign substance
Missing from associated official evidence: action.
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Missing from associated official evidence: action.
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical interventi...
Missing from associated official evidence: action, consumer scope.
Product not adequately pasteurized
Missing from associated official evidence: action.
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Missing from associated official evidence: action.
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the...
Missing from associated official evidence: action, consumer scope.
potential salmonella contamination
Missing from associated official evidence: action.
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result i...
Missing from associated official evidence: action, consumer scope.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended de...
Missing from associated official evidence: action, consumer scope.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Missing from associated official evidence: action, consumer scope.
Undeclared allergens: Milk and Soy
Missing from associated official evidence: action.
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Missing from associated official evidence: action.
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Missing from associated official evidence: action, consumer scope.
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
Missing from associated official evidence: action, consumer scope.
sub potency
Missing from associated official evidence: action.
Lack of Assurance of Sterility
Missing from associated official evidence: action.
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich
Missing from associated official evidence: action.
CGMP Deviations
Missing from associated official evidence: action.
Potential Salmonella contamination
Missing from associated official evidence: action.
