# FDA recall Z-0084-2024

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

## Product

Procedure packs:    (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;  (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular.  (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile;  (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile;  (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile;  (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile;  (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile;  (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile;  (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile;  (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile;  (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile;  (12) Presource Implant Pack, Cat. SAN21IP62I, 

## 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-0084-2024
- **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-0084-2024

## Citation

> AI Analytics. FDA recall Z-0084-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0084-2024. Source: US FDA. Licensed CC0.

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