Monoject Insulin Syringe

• • Terminated Z-0284-2009 FDA Unclassified (pre-2012) ·initiated 9 Oct 2008

  Mislabeled: Package labeled as an insulin syringe for use with U-100 insulin contains an insulin syringe for use with U-40 insulin. Risk of overdose of insulin.

510(k) Number

K033373 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K070685 Active Cleared 14 Sep 2007

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• Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe Open recall

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  Class II

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  Class II

  FDA 510(k) K032827 Active Cleared 8 Dec 2003

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