Navilyst Medical, Inc: Medical Device Recall in 2015 - (Recall #: Z-1165-2015)

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/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, 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-1165-2015

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: 105 units

Code Information:

Lots 4268419, 4310080, 4344788, 4393891, 4416012, 4462784, 4535382, 4575640, 4608478, 4624082, 4641213, 4666593, 4680409, 4689497, 4696721, 4707605, 4730974, 4742627, 4759572, 4772627, 4782953, 4793007, 4793974, 4824273.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated