Auto Syringe Micro Vol Ext Set W/Air Vent Filter

• 2 recalls, same reason

  • Terminated Z-0520-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002 ·on shared 510(k) K860746
  • Terminated Z-0521-03 FDA Unclassified (pre-2012) ·initiated 17 Oct 2002 ·on shared 510(k) K860746

  The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K860746 ↗

FDA Product Code

FPB

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Travenol Laboratories, S.A. →

• What is the Auto Syringe Micro Volume Extension Set with Air Vent Filter used for?

  This device is designed for the controlled administration of small volumes of fluids in clinical settings. It combines an automatic syringe mechanism with an extension set and an integrated air vent filter to ensure precise delivery of medications or fluids while minimizing air entrainment. This reduces the risk of air embolism and maintains fluid flow integrity during infusion procedures.

• How is the Auto Syringe Micro Volume Extension Set supplied, and is it sterile?

  The device is supplied sterile and packaged for aseptic handling, ensuring it is ready for immediate single-use in hospital environments. No additional sterilization is required after opening, as it is intended for one-time use only.

• Is this device reusable, or is it intended for single-use only?

  This device is explicitly designed for single-use only. It is not intended to be reused or reprocessed, as this could compromise sterility and safety. The packaging ensures aseptic handling for one controlled administration procedure.

• What regulatory classification does this device hold, and where is it authorized?

  The Auto Syringe Micro Volume Extension Set with Air Vent Filter is classified as a Class II medical device under FDA regulation 880.5440. It is authorized for use in general hospital environments and holds an FDA 510(k) clearance (K860746), confirming its substantial equivalence to a predicate device.

• How does the air vent filter contribute to the safety of fluid administration?

  The integrated air vent filter ensures minimal air entrainment during infusion, which significantly reduces the risk of air embolism—a potentially serious complication during fluid administration. By maintaining fluid flow integrity while filtering out air bubbles, it enhances the safety and precision of micro-volume infusions.