PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 15, 2020 Initiated: June 4, 2020 #Z-2543-2020

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
3000
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Location
Waukegan, IL

Frequently Asked Questions

What product 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.. Recalled by Cardinal Health 200, LLC. Units affected: 3000.
Why was this product recalled?
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2543-2020.