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VariSoft Infusion Set (Unomedical A/S) – Connector Damage (2023)

The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.

High

FDAOct 11, 2023Nationwide• Unomedical A/S Aaholmvej

BD Alaris Pump Infusion Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

Moderate

FDAOct 11, 2023Nationwide

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VariSoft Infusion Set (Unomedical A/S) – Connector Damage (2023)

BD Alaris Pump Infusion Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Nautilus ECMO Oxygenator (Unknown) – heat exchange problem (2023)

Medline Resuscitator (SunMed) – CO2 rebreathing risk (2023)

BreathTech Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

V-Care Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

BD Extension Sets (Becton Dickinson) – DEHP Mislabeling (2023)

BD Gravity Sets (Becton Dickinson) – DEHP Mislabeling (2023)

Horizon Manual Resuscitators (SunMed Holdings) – CO2 Rebreathing Risk (2023)

VITROS 5600 System (Ortho-Clinical) – Software Issues (2023)

Xstar Kojo Safety Slit Knife (Beaver Visitec) – Incorrect Bevel (2023)

Stay Safe Cap (Fresenius Medical) – Additional Warnings (2023)

CARDIOHELP Emergency Drive (Maquet) – Patient Exposure Risk (2023)

VITROS XT 7600 System (Ortho-Clinical) – Software Issues (2023)

VITROS 4600 System (Ortho-Clinical) – Software Issues (2023)

VITROS 3600 System (Ortho-Clinical) – Software Issues (2023)

VITROS XT 3400 System (Ortho-Clinical) – Software Issues (2023)

Compress Device Short Anchor Plug (Biomet) – Metal Burr Risk (2023)

Zemits NDPrime Laser (Advance-Esthetic) – Radiation Control Violation (2023)

Spectral CT on Rails (Philips) – IVC Needle Position Issue (2023)