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HydroPICC 5Fr Dual Lumen Kit (Access Vascular) – incorrect IFU (2023)

Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.

Low

FDAAug 31, 2023Nationwide• Access Vascular, Inc

EarlyVue VS30 Vital Signs Monitor (Philips) – respiration rate alarm issue (2023)

A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.

Moderate

FDAAug 31, 2023Nationwide• Philips North America Llc

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HydroPICC 5Fr Dual Lumen Kit (Access Vascular) – incorrect IFU (2023)

EarlyVue VS30 Vital Signs Monitor (Philips) – respiration rate alarm issue (2023)

HydroPICC 5Fr Dual Lumen Maximal Kit (Access Vascular) – incorrect IFU (2023)

API3200MD Mass Spectrometer (AB Sciex) – flame risk (2023)

ProCuity Bed Series (Stryker) – electrical safety test missing (2023)

Citrine QTRAP Mass Spectrometer (AB Sciex) – flame risk (2023)

CellQuicken Analyzer (RoyalVibe) – unauthorized device (2023)

ProCurity Bed Series (Stryker) – electrical safety test missing (2023)

4500MD Triple Quad Mass Spectrometer (AB Sciex) – flame risk (2023)

Citrine Triple Quad Mass Spectrometer (AB Sciex) – flame risk (2023)

BD Cathena Safety IV Catheter (Becton Dickinson) – shield engagement problem (2023)

Carter-Thomason CloseSure System (CooperSurgical) – component description error (2023)

Arjo Medical Beds (ArjoHuntleigh) – wheel movement issue (2023)

Coventus Flex-Thread Cannulated Reamer (Flower Orthopedics) – device breaking (2023)

PRIMA TT Glenoid Baseplate (Limacorporate) – manufacturing hole issue (2023)

Detector H. Pylori Test (Immunostics) – incorrect expiration date (2023)

V60/V60 Plus Ventilator (Philips Respironics) – power management failure (2023)

Multichem IA Plus (Techno-Path) – glass vial commodity problem (2023)

Conventional Knife Crescent (Beaver Visitec) – incorrect blade orientation (2023)

Multichem S Plus (Techno-Path) – glass vial commodity problem (2023)