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.
Z-2544-2020
Product summary
- Event
- Event 85803
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1960
- Official record key
device-enforcement:Z-2544-2020
Official wording
Reason: Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
Code information: Model Numbers: 48-4000, Lot numbers:201829015, 201923314, 201923316, 201923319, 20192347, 201923414, 201923410.
Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Canada.
Derived failure modes
-
Unknown
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.