Cardinal Health NPWT Canister with Gel 300cc — Class II medical device recall Z-2543-2020
Terminated recall by Cardinal Health 200, LLC, reported 2020-07-15, distributed nationwide. Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the de
| Recall number | Z-2543-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2020-06-04 |
| Classified | 2020-07-09 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2025-08-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,000 |
| Lot numbers | 201921913, 201921915, 201921919, 201922009, 201922017, 201922019, 201922021, 201922118, 201922120, 201922121, 201922419, 201922421 |
| Model numbers | 47-4000 |
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 for recall
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2543-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.