Resource Optimization & Innovation Llc: Medical Device Recall in 2015 - (Recall #: Z-0188-2016)

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:

Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.

Product Classification:

Class II

Date Initiated: August 25, 2015

Date Posted: November 4, 2015

Recall Number: Z-0188-2016

Event ID: 72052

Reason for Recall:

Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

Status: Terminated

Product Quantity: 57 kits

Code Information:

19532, 27389, 24399, and 24478

Distribution Pattern:

Distributed in Texas and Louisiana.

Voluntary or Mandated:

Voluntary: Firm initiated