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All product recalls affecting Alabama.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Alabama in the distribution area.
A limited number of IV bags have been found to leak during filling.
A limited number of IV bags have been found to leak during filling.
There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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.
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Pirelli Tire, LLC. (Pirelli) is recalling certain Scorpion Trail II, Metzeler Tourance Next, and Next II tires sold as replacements and for the Metzeler Tourance Next 150/70R18 M/C 70V tire, also installed as original equipment on certain Triumph motorcycles. Please refer to the recall report for specific sizes. Irregular tire wear may break the belt reinforcement, causing pieces of the tread to separate.
Affected device lots have labels that state the incorrect expiration dates.
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.