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LNOP TC-I SpO2 Ear Sensor (Masimo) - Reading Accuracy Problem (2023)

TC-I tip clip sensor may produce readings outside the accuracy specification.

FDAApr 21, 2023AL, AK, AZ +49 more• Masimo Corporation

Magic3 Go Urinary Catheters (C.R. Bard) - Label Separation Risk (2023)

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

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FDAApr 20, 2023Nationwide• C.R. Bard Inc

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LNOP TC-I SpO2 Ear Sensor (Masimo) - Reading Accuracy Problem (2023)

Magic3 Go Urinary Catheters (C.R. Bard) - Label Separation Risk (2023)

HydroSil Go Urinary Catheters (C.R. Bard) - Label Separation Risk (2023)

Lidocaine Patch (Bryant Ranch) – Labeling Error (2023)

Patient Information Center iX (Philips) - DHCP Lease Expiration (2023)

Seatex Alcohol Sanitizer – Specification Failure (2023)

Single Use Distal Cover (Olympus) - Mucosal Injury Risk (2023)

VITROS HbA1c Reagent Kit (Ortho-Clinical) - Result Inaccuracy (2023)

Impella 5.5 Catheter (Abiomed) - Purge Leak Concern (2023)

Total Knee Pack (American Contract Systems) - Expiration Date Error (2023)

Sterile Surgical Procedure Packs (DeRoyal) - Handle Cover Issue (2023)

Cocktail Sauce (Washington Crab & Seafood) – Undeclared Fish (2023)

VITROS Chemistry Calibrator Kit (Ortho-Clinical) - Calibration Problem (2023)

Starrsed Control Level N (Mechatronics) - Mislabeling Issue (2023)

Starrsed Control Level A (Mechatronics) - Mislabeling Issue (2023)

Cole Slaw (Washington Crab & Seafood) – Undeclared Allergens (2023)

Blue Crab Dip (Washington Crab & Seafood) – Undeclared Milk (2023)

Impad Rigid Sole Foot Cover (Stryker) - DVT Sleeve Mislabeling (2023)

Crabcake (Washington Crab & Seafood) – Undeclared Allergens (2023)

BIOKNOTLESS Rapid Anchor (DePuy Mitek) - Inserter Tip Fragment Risk (2023)