# FDA recall Z-0085-2024

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2023-08-16.

## Product

Procedure pack:  Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

## Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV.  There was government distribution and no military distribution. The country of Canada.

## Key facts

- **Recall number:** Z-0085-2024
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-16
- **Report date:** 2023-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2024

## Citation

> AI Analytics. FDA recall Z-0085-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0085-2024. Source: US FDA. Licensed CC0.

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