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MYNXGRIP Vascular Closure Device (Cordis) – Incorrect Label (2023)

Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.

Moderate

FDANov 28, 2023CA, MI, MS +4 more• Cordis US Corp

Patient Information Center (Philips) – Push Notification Failure (2023)

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

Moderate

FDANov 28, 2023Nationwide• Philips North America

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MYNXGRIP Vascular Closure Device (Cordis) – Incorrect Label (2023)

Patient Information Center (Philips) – Push Notification Failure (2023)

MYNXGRIP Vascular Closure Device (Cordis) – Incorrect Label (2023)

Scoot Control R-net (mo-Vis) – Throttle Lever Stuck (2023)

VITROS Anti-HBs Quantitative Reagent – Calibration Failures (2023)

BIOFIRE Respiratory Panel – False Negative Results (2023)

BIOFIRE Gastrointestinal Panel – False Negative Results (2023)

RibLoc U Plus 90 Instrument – Potential Breakage (2023)

Captus 4000e Thyroid Uptake System – Spring Arm Failure (2023)

Trilogy Evo Respirator – Missing Contraindication Statement (2023)

Actim PROM Dipstick – Lubricant Interference (2023)

Fujifilm Mobile X-Ray System – Incorrect Default Settings (2023)

DeRoyal Cardiac Cath Kit – Recalled Transducer (2023)

Exactech Vantage Ankle System – Vacuum Bag Loss (2023)

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Exactech Novation Hip System – Vacuum Bag Loss (2023)

Exactech Equinoxe Reverse Shoulder System – Vacuum Bag Loss (2023)

QMS Tacrolimus Calibrators – Improper Storage (2023)

Exactech Optetrak Knee System – Vacuum Bag Loss (2023)