KIT — Class II medical device recall Z-3016-2020
Terminated recall by Cardinal Health 200, LLC, reported 2020-10-07, distributed nationwide. Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
| Recall number | Z-3016-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Fort Mill, SC, United States |
| Recall initiated | 2020-07-30 |
| Classified | 2020-09-25 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 9,150 kits |
| Lot numbers | 558357, 561502, 566549, 571467, 574058 |
| Model numbers | ORPDH5994A |
Product
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Reason for recall
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
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-3016-2020. 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.