FDA recall Z-2544-2020

Cardinal Health 200, LLC · Class II · device

Product

Cardinal Health NPWT Occlusion Detection Canister 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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-06-04
Report date
2020-07-15
Termination date
2025-08-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2020