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Vancomycin Hydrochloride 250 mg Capsules (Actavis) – subpotent drug (2014)

Subpotent Drug

FDAAug 25, 2014Nationwide• Actavis Inc

BioFlo Hybrid PICC Kit (Navilyst) – Syringe Flush Issue (2014)

NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

Class IIModerate

FDA

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Vancomycin Hydrochloride 250 mg Capsules (Actavis) – subpotent drug (2014)

BioFlo Hybrid PICC Kit (Navilyst) – Syringe Flush Issue (2014)

BioFlo PICC Kit (Navilyst) – Syringe Flush Issue (2014)

PICC Kit with PASV Valve (Navilyst) – Syringe Flush Issue (2014)

PICC Kit with PASV Valve (Navilyst) – Syringe Flush Issue (2014)

PICC Kit with PASV Valve (Navilyst) – Syringe Flush Issue (2014)

BioFlo PICC with PASV Valve (Navilyst) – Syringe Flush Issue (2014)

PICC Kit with PASV Valve (Navilyst) – Syringe Flush Issue (2014)

BioFlo PICC Kit (Navilyst) – Syringe Flush Issue (2014)

Vancomycin Hydrochloride 125 mg Capsules (Actavis) – subpotent drug (2014)

PICC Convenience Kit (Navilyst) – Syringe Flush Issue (2014)

PICC Kit with PASV Valve (Navilyst) – Syringe Flush Issue (2014)

PICC Convenience Kit (Navilyst) – Syringe Flush Issue (2014)

SafeLiner Suction Canister (DeRoyal) – Insufficient Seal (2014)

Suction Canister (DeRoyal) – Insufficient Seal (2014)

MR Systems (Philips) – Image Order Reversal (2014)

TEGRIS System (Maquet) – Movement Control Error (2014)

UniCel Immunoassay System (Beckman) – Sample Probe Issue (2014)

VITROS Phenytoin Slides (Ortho) – Biased Test Results (2014)

Hercules Stabilizing Arm (Terumo) – Pin Failure Risk (2014)