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A limited number of IV bags have been found to leak during filling.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Affected device lots have labels that state the incorrect expiration dates.
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
CGMP violations.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.