Z-2544-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- June 4, 2020
- Termination Date
- August 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1960
Product Description
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 Pattern
Worldwide distribution - US Nationwide distribution and the country of Canada.
Code Information
Model Numbers: 48-4000, Lot numbers:201829015, 201923314, 201923316, 201923319, 20192347, 201923414, 201923410.