Navilyst Medical, Inc: Medical Device Recall in 2015 - (Recall #: Z-1207-2015)

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 H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683. 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-1207-2015

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: 133 units

Code Information:

Lots 4244975, 4251615, 4269276, 4292593, 4310081, 4344776, 4374583, 4384503, 4413658, 4447492, 4505410, 4535348, 4569287, 4572788, 4604137, 4610092, 4612832, 4630601, 4630602, 4638044, 4681013, 4690175, 4705330, 4717942, 4731420, 4772544, 4812433.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated