FDA Device recall Z-3016-2020
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus
- FDA Device
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus by Cardinal Health 200, citing only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3016-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-30 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Reason
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
Identifiers
| code_info | Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3016-2020%22
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