FDA-Device2020-07-15Class II
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.
Cardinal Health 200, LLC
Hazard
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
Sold states
Worldwide distribution - US Nationwide distribution and the country of Canada.
Affected count
3000
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2020Don't want to check this manually?
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