# Class II recall Z-0079-2027: Cardinal Health 200, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0079-2027 |
| Recalling firm | Cardinal Health 200, LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Presource Packs containing Medtronic Microstream Components:    Intubation Kit  Catalog Numbers   AN23366084  AN23366085  AN2336608H  AN2336608J    Intubating Bag Kit  Catalog Number OMSVM4166A    Intubation UH Kit  Catalog Number AN2336608G |
| Reason | Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation. |
| Quantity | 210 total kits |
| Distribution | Pending |
| Recall initiated | 2026-08-19 |
| Reported | 2026-10-14 |
| Firm location | Waukegan, IL, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 21 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0079-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.