Recall Z-2543-2020— Cardinal Health 200, LLC
Class II · Terminated
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2020-06-04, terminated 2025-08-05. It names one FDA 510(k) clearance: K143016. 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.. Reason: Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-04
- Terminated
- 2025-08-05
- Firm location
- Waukegan, IL, United States
510(k) clearances named in this recall
1 on FDA's record- K143016 — Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.