FDAFDA · Food and drugs·Recall number Z-2543-2020
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.
Published July 15, 2020 · Recall initiated: June 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- Worldwide distribution - US Nationwide distribution and the country of Canada.
- Lot
- Model Numbers: 47-4000, Lot numbers:201921913, 201921915, 201921919, 201922009, 201922017, 201922019, 201922021, 201922118, 201922419, 201922120, 201922121, 201922421
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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