# FDA recall Z-0089-2024

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

## Product

Procedure packs:    (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile;  (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile;  (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile;  (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile;  (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile;  (6) Presource PBDS Cat. PN40CD806,  Kit, Pedi C D, RWJ, Sterile;  (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile;  (8) Presource PBDS Cat. PN73APVD7,  Kit, Neuro Spine Module, Sterile;  (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile;  (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile;  (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile;  (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile;  (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile;  (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile;  (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile;  (16) Presource Cervical Spine

## 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-0089-2024
- **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-0089-2024

## Citation

> AI Analytics. FDA recall Z-0089-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0089-2024. Source: US FDA. Licensed CC0.

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