Resource Optimization & Innovation Llc recalls regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit containing cover light handle soft, RX…

Recall date

April 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0062-2016

FDA classification

Class II

Brand / firm

Resource Optimization & Innovation Llc

Sold / distributed

Distribution was made to LA, MS, and TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - 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