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Luxury Isopropyl Alcohol (Tsm Brands) – Undeclared Alcohol (2022)

Undeclared Allergen

Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol

Class IIModerate

FDAJul 19, 2022IN, VA• Tsm Brands LLC

Roadrunner UniGlide Wire Guide (Cook) – Packaging Sterility Issue (2022)

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.

Moderate

FDAJul 19, 2022Nationwide• Cook Incorporated

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Luxury Isopropyl Alcohol (Tsm Brands) – Undeclared Alcohol (2022)

Roadrunner UniGlide Wire Guide (Cook) – Packaging Sterility Issue (2022)

BD PhaSeal Y-Site Connector (Becton Dickinson) – Incorrect Expiration (2022)

Fancy Buckwheat Flour (Minn Dak) – foreign material (2022)

Dimension Vista LOCI CA 15-3 (Siemens) – Sample Bias Risk (2022)

Centricity Universal Viewer (GE Healthcare) – Measurement Inaccuracy (2022)

Aesculap Ennovate Set Screw (Aesculap) – Potential Incorrect Screw (2022)

ARIES SARS-CoV-2 Assay (Luminex) – Gene Detection Limitation (2022)

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Exacta-Mix 2400 System (Baxter) – Valve Leakage Potential (2022)

EverFlex Peripheral Stent (Medtronic) – Deployment Workaround (2022)

Truffle Arancini (Kabobs Acquisition) – glass contamination (2022)

Tomato Basil Arancini (Kabobs Acquisition) – glass contamination (2022)

VITEK 2 System (bioMerieux) – Software Anomalies (2022)

Grappler Suture Anchor (Paragon 28) – Potential Breakage (2022)

TaperFit Stem (Corin) – Fatigue Testing Failure (2022)

HXBL Viral Transport Container (Haimen Shengbang) – Distribution Guidance Violation (2022)

Surpria 64 Software (FUJIFILM) – Scanning Error Risk (2022)

Surpria Software (FUJIFILM) – Scanning Error Risk (2022)

SCENARIA View Software (FUJIFILM) – Scanning Error Risk (2022)