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Recall Observatory FDA recall evidence

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

June 04, 2020

Class II

Product summary

Firm
Cardinal Health 200, LLC
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

    reason.no_named_rule · v1.0.0

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