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Monoject Syringe 12mL (Cardinal Health) – Product Correction (2023)

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

High

FDADec 28, 2023Nationwide• Cardinal Health 200, LLC

Monoject Enteral Syringe 6mL (Cardinal Health) – Compatibility Issue (2023)

The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

High

FDADec 28, 2023Nationwide

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Monoject Syringe 12mL (Cardinal Health) – Product Correction (2023)

Monoject Enteral Syringe 6mL (Cardinal Health) – Compatibility Issue (2023)

Monoject Syringe 35mL (Cardinal Health) – Product Correction (2023)

FentaNYL Citrate IV Solution (Denver Solutions) – Double Dose Risk (2023)

FentaNYL Citrate Large IV Solution (Denver Solutions) – Double Dose Risk (2023)

VANCOmycin HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

Vancomycin IV Bag (Denver Solutions) – Dosage Malfunction (2023)

Original No Drip Nasal Spray (Seaway Pharma) – Microbial Contamination Risk (2023)

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Sterility Concern (2023)

Quality Choice Severe Congestion Nasal Mist (Seaway Pharma) – Microbial Contamination Risk (2023)

PHENYLephrine HCl Lower Dose IV Solution (Denver Solutions) – Double Dose Risk (2023)

Premier Value Tussin Cough DM (Seaway Pharma) – Microbial Contamination Risk (2023)

Quality Choice No Drip Nasal Pump Mist (Seaway Pharma) – Microbial Contamination Risk (2023)

PHENYLephrine HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

TruScan Body (TruAbutment) – scanning accuracy problems (2023)

Impella Catheters (Abiomed) – myocardial wall risk (2023)

Impella Catheters (Abiomed) – fiber contamination risk (2023)

GE Lullaby Incubator (GE Healthcare) – bedside panel issue (2023)

GE Neonatal Incubator (GE Healthcare) – bedside panel problem (2023)

GE Care Plus Hood (GE Healthcare) – bedside panel issue (2023)