Navilyst Medical, Inc: Medical Device Recall in 2015 - (Recall #: Z-1167-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Product Classification:

Class II

Date Initiated: January 9, 2015

Date Posted: March 4, 2015

Recall Number: Z-1167-2015

Event ID: 70322

Reason for Recall:

The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.

Status: Terminated

Product Quantity: 64 units

Code Information:

Lots 4268921, 4310402, 4317001, 4384580, 4442479, 4500790, 4504919, 4599070, 4645482, 4661978, 4680493, 4704381, 4742117, 4777180, 4801317.

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

Voluntary or Mandated:

Voluntary: Firm initiated