Navilyst Medical, Inc: Medical Device Recall in 2015 - (Recall #: Z-1193-2015)

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, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 600207212, STERILE, Rx ONLY --- For single use only. ---Device Listing Number D136588. 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-1193-2015

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: 18 units

Code Information:

Lots 4652732, 4656169, 4657278, 4673716, 4694148, 4729301, 4748825, 4778748, 4790216, 4816281, 4817327, 4830491.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated