Resource Optimization & Innovation Llc: Medical Device Recall in 2015 - (Recall #: Z-0072-2016)

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: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Product Classification:

Class II

Date Initiated: April 22, 2015

Date Posted: October 14, 2015

Recall Number: Z-0072-2016

Event ID: 71904

Reason for Recall:

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Status: Terminated

Product Quantity: 108 kits

Code Information:

Lot numbers 16917, 19985, and 22799.

Distribution Pattern:

Distribution was made to LA, MS, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated