Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
Devices were delivered without the required dry ice.
Class I - Dangerous
Devices were delivered without the required dry ice.
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
Abbott Ireland Diagnostics Division
Class I - Dangerous
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Class I - Dangerous
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Class I - Dangerous
Devices were delivered without the required dry ice.
Class I - Dangerous
Devices were delivered without the required dry ice.
Class I - Dangerous
Devices were delivered without the required dry ice.
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
Abbott Ireland Diagnostics Division
Class I - Dangerous
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Cardinal Health 200
Class I - Dangerous
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap