Fresenius Medical Care Holdings NaturaLyte Liquid Acid concentrate bottles, Model Number recall — FDA Z-0822-2021
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Complete FDA and NHTSA recall records dated in 2021, organized for browsing by month, category and recalling company.
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Records are ordered by the best available source date.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to…
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely…
When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can…
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
Undeclared allergen; tree nuts (cashews).
B&G Foods, Inc. has initiated a recall because their garlic powder mistakenly had bacon-flavored bits, which contain soy, an allergen undeclared on the garlic powder labels.
Washington State Department of Agriculture samples product and had a positive result of Listeria monocytogenes.
Product is potentially contaminated with Salmonella.
Ground Tuna may contain elevated levels of Histamine.
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
cGMP deviations: Product made at the same facility where product tested was sub-potent.
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and…
Ford Motor Company (Ford) is recalling certain 2020-2021 Edge, 2020 Lincoln Nautilus and Ford Escape and 2021 Lincoln Corsair and Ford Bronco Sport vehicles. An inadequate amount of…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.