ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0131-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Complete FDA and NHTSA recall records dated in October 2019.
These records include useful source details for the selected month.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
The sterile barrier of some devices may have been affected
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
The sterile barrier of some devices may have been affected
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
The bottled water contains bromate levels in excess of the 0.010 mg/L FDA standard of quality limit.
Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
Products were labeled with incorrect ingredient listing. The ingredients listed on the label include multiple allergens (almonds, cashews, coconut, hazelnuts, peacans, walnuts, cashews,…
Product is contaminated with norovirus.
Product contains undeclared sulfites.
Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
Northern Fisheries Ltd. was notified by two of their customers that they each received several consumer complaints from consumers who experienced symptoms of scombroid (histamine) poisoning…
Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
The product ingredient statement does not list walnuts in the product.
Northern Fisheries Ltd. was notified by two of their customers that they received several consumer complaints from consumers who experienced symptoms of scombroid (histamine) poisoning…
Products were labeled with incorrect ingredient listing. The ingredients listed on the label include multiple allergens (almonds, cashews, coconut, hazelnuts, pecans, walnuts, peanuts).…
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Superpotent
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.