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All product recalls affecting Florida.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Florida in the distribution area.
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Affected device lots have labels that state the incorrect expiration dates.
CGMP violations.
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 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.
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.
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.
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 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 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.
Patulin. Apple Cider was found to have elevated levels of patulin after receiving analytical testing results from 3rd party laboratory. Lab sample detected 78 ppb; limit is 50 ppb.
Patulin. Apple Cider was found to have elevated levels of patulin after receiving analytical testing results from 3rd party laboratory. Lab sample detected 78 ppb; limit is 50 ppb.
Patulin. Apple Cider was found to have elevated levels of patulin after receiving analytical testing results from 3rd party laboratory. Lab sample detected 78 ppb; limit is 50 ppb.
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.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.