ICU Medical 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check recall — FDA Z-1724-2022
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Complete FDA and NHTSA recall records dated in 2022, organized for browsing by month, category and recalling company.
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Records are ordered by the best available source date.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and…
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on…
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
The firm was notified by a customer that the bottle contains green and white capsules instead of the usual white round tablets. They contacted their manufacturer to investigate the issue…
Undeclared cashews
cleaning solution, which is used on food processing equipment, was inadvertently introduced into a production line
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Chemical contamination: presence of benzene
Microbial contamination of non-sterile products.
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
CGMP Deviations
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
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.