Cardinal Health 200, LLC recalls Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on pa…

Recall date

June 4, 2020

Source

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

Recall number

Z-2543-2020

FDA classification

Class II

Brand / firm

Cardinal Health 200, LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution and the country of Canada.

Why it was recalled

Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

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

What was recalled

Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.