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Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Presence of Foreign Tablets/Capsules
Superpotent; sodium benzoate preservative
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
Due to an observed trend of neurovascular events
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
Due to devices being irradiated above the established specification which my result in package integrity issues.
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.