Navilyst Medical, Inc: Medical Device Recall in 2015 - (Recall #: Z-1166-2015)

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 CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. 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-1166-2015

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: 62 units

Code Information:

Lots 4361877, 4362670, 4384555, 4475742, 4534905, 4534906, 4572742, 4573424, 4603617, 4613738, 4623233, 4641655, 4642470, 4649930, 4654858, 4662098, 4666862, 4667793, 4672390, 4680972, 4681793, 4690126, 4696307, 4702956, 4706317, 4716358, 4726251, 4736913, 4747725, 4766391, 4778794, 4816062, 4820335, 4824146, 4834213.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated