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Plum Solos Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

High

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Codman Disposable Perforator Kit (Medline) – Weld Inadequacy (2025)

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

High

FDAApr 22, 2025CA, FL, IL +10 more• MEDLINE INDUSTRIES, LP Northfield

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Plum Solos Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Codman Disposable Perforator Kit (Medline) – Weld Inadequacy (2025)

Catalyst+ C4D Software (C-RAD) – Scanning Equipment Error (2025)

3M Ranger Irrigation Set (3M) – Flow Rate Clarification (2025)

Clindamycin HCl Capsules (RemedyRePack) - CGMP Issues (2025)

Plum Duo Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)

BD Cathena IV Catheter (BD) – Septum Defect Risk (2025)

Precision Sampling Set (Capnia) – Contamination Risk (2025)

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

EVENITY Injection (Mckesson) - Temperature Excursion (2025)

BENLYSTA Injection (Mckesson) - Temperature Excursion (2025)

PROLIA Injection (Mckesson) - Temperature Excursion (2025)

Monkfish Liver (JJWV Marketing) – Undeclared Milk (2025)

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Clindamycin Hydrochloride Capsules (Preferred Pharmaceuticals) - CGMP Issues (2025)

Timolol Maleate Eye Solution (FDC Limited) - Defective Container (2025)

Bard Intragastric Balloon Tube (C.R. Bard) – Plug Removal (2025)