Drug recall
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for…
FDA recall event 85803 · Class II · Cardinal Health 200, LLC
Key facts
| Event ID | 85803 |
|---|---|
| Recall numbers | Z-2543-2020, Z-2544-2020 |
| Recalling firm | Cardinal Health 200, LLC |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| Initiation date | Jun 4, 2020 |
| Report date | Jul 15, 2020 |
| Termination date | Aug 5, 2025 |
| City | Waukegan |
| State | IL |
| Country | United States |
| FEI number | 3001236905 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: