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Unapproved Drug Claims and Misbranded.
Allergen labeling: missing allergens (peanuts, milk) in contains statement
Allergen labeling: egg is not listed in the 'contains' statement
Allergen labeling: specific tree nut (pecans) not listed in the 'contains' statement
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Presence of foreign substance: identified as aluminum.
Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Due to incomplete seals in the pouch which provide the sterile barrier.
Imported Frozen Oyster potentially contaminated with Norovirus.
Potential for spoilage due to yeast contamination.