Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–18 of 18 recalls
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Potential that the induction seal is not completely sealed to the device tube packaging.