The Recall Desk
ModerateFDA (Devices)·Z-0084-2024·Announced 2023-10-18

Cardinal Health surgical procedure packs recalled for defective components

Cardinal Health is recalling 13,351 surgical procedure packs containing recalled components including equipment drapes, table covers, and surgical room turnover kits.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or detailed hazard specification stated in the source. Per the rubric, recalls with theoretical hazards and no reported harm are classified as Moderate.

Plain-English summary

Cardinal Health 200, LLC is recalling 13,351 surgical procedure packs that contain recalled components, including equipment drapes, table covers, and surgical room turnover (SRT) kits used in surgical procedures at healthcare facilities.

The affected packs have been distributed nationwide across 34 U.S. states (Arizona, California, Colorado, Connecticut, Washington DC, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and West Virginia) and in Canada. Multiple lots with specific expiration dates have been identified.

Healthcare facilities that received these recalled packs should immediately discontinue use and contact Cardinal Health for return or replacement instructions. Healthcare providers should report any adverse events or concerns to the FDA.

The recalled product

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
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Supplies
Hazard
  • component-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (1) Cat. PC71EXOU7 - Lot #916915
  • Exp. 5/1/2024
  • UDI-DI 10195594873332
  • (2) Cat. PVOCMVBLC - Lot #922978
  • Exp. 10/1/2024
  • and Lot #922978
  • Exp. 7/1/2024
  • UDI-DI 10195594763183
  • (3) Cat. PVRMMVAOH7 - Lot #923996
  • Exp. 1/1/2024
  • UDI-DI 10195594892777
  • (4) Cat. PV30VPUHA - Lot #898892
  • Exp. 2/1/2024
  • UDI-DI 10195594485894
  • (5) Cat. SANOCCPDM2 - Lot #920122
  • Exp. 6/1/2025
  • UDI-DI 10195594882273
  • (6) Cat. SAN1FPMULM - Lot #929016
  • Exp. 6/1/2024
  • UDI-DI 10195594712938

Distribution

Distributed nationwide across the United States.

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