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Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

CareStation 650 A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

Moderate

FDAMar 21, 2025Nationwide

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Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

CareStation 650 A1 (GE Healthcare) – ventilation ineffective (2025)

Connex Vital Signs Monitor (Baxter) – undeclared rubber band (2025)

OEC Elite (GE Medical) – X-ray field distance issue (2025)

CareStation 750c A1 (GE Healthcare) – ventilation ineffective (2025)

DxC 500 AU Analyzer (Beckman Coulter) – calibration software error (2025)

Alinity m System (Abbott Molecular) – liquid waste risk (2025)

Cerene Cryotherapy Device (Channel Medsystems) – gasket seal issue (2025)

GenetiSure Dx Kit (Agilent) – DNA labeling component (2025)

VASOVIEW HEMOPRO 2 (Maquet) – ceramic C-Ring breakage (2025)

epoc BGEM Crea Test Card (Siemens) – pH result discrepancy (2025)

epoc BGEM BUN Test Card (Siemens) – pH result discrepancy (2025)

Quantum Informatics VIPER (Spectrum Medical) – FDA clearance (2025)

Sterile Normal Saline (Medline) – bottle leakage issue (2025)

Ballard Closed Suction Catheters (Avanos) – sterility concern (2025)

Sterile Water (Medline) – bottle leakage issue (2025)

Brioche Bread and Buns (Baking Group) – Undeclared Allergens (2025)

Turkey BLT on Sourdough (Hearn Kirkwood) – Incorrect Sandwich (2025)

Procedure Kits (Medline) – bottle leakage issue (2025)

CELL-DYN Ruby (Abbott) – reagent expiration error (2025)