ROi Consolidated Service Center (CSC) recalls Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneu…

Recall date

March 21, 2019

Source

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

Recall number

Z-2221-2019

FDA classification

Class II

Brand / firm

ROi Consolidated Service Center (CSC)

Sold / distributed

Distributed to LA and MO

Why it was recalled

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

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 ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.