Device product
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.
Z-2543-2020
Product summary
- Event
- Event 85803
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3000
- Official record key
device-enforcement:Z-2543-2020
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: 47-4000, Lot numbers:201921913, 201921915, 201921919, 201922009, 201922017, 201922019, 201922021, 201922118, 201922419, 201922120, 201922121, 201922421
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.