The Recall Desk
ModerateFDA (Devices)·Z-0087-2024·Announced 2023-10-18

Surgical Procedure Packs Recalled Due to Recalled Components

Cardinal Health is recalling 13,351 surgical procedure packs containing previously recalled components including equipment drapes, table covers, and surgical room turnover kits distributed nationwide in the US and Canada.

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 medical device recall with no reported illnesses or injuries. The recall appears precautionary due to incorporation of previously recalled components, without a specified defect mechanism or reported patient harm.

Plain-English summary

Cardinal Health 200, LLC is recalling 13,351 surgical procedure packs that contain recalled components. The affected products include equipment drapes, table covers, and surgical room turnover kits packaged into various procedure kits used for different surgical procedures.

The recalled procedure packs were distributed nationwide across multiple US states (including 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) as well as Canada. The packs were distributed to hospitals and medical facilities.

Healthcare providers who received these procedure packs should stop use and verify whether they have received any of the affected products. Patients who may have been treated with materials from these procedure packs should consult with their healthcare provider if they have concerns.

The recalled product

Product
Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical / Procedure Packs
Hazard
Affected units
13,351

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. PGMHSUESR - Lot #54698
  • Exp. 2/1/2025 and Exp. 6/1/2024
  • UDI-DI 10195594542757
  • (2) Cat. PGVGLBP20 - Lot #921831
  • Exp. 4/1/2024
  • UDI-DI 10195594892210
  • (3) Cat. PG63CCC31 - Lot #940845
  • Exp. 9/1/2023
  • UDI-DI 10197106032978
  • (4) Cat. PG63CCC34 - Lot #46817
  • Exp. 2/1/2024
  • UDI-DI 10197106279342
  • (5) Cat. SBAOCRBENF - Lot #985693
  • Exp. 7/1/2024
  • UDI-DI 10195594735999
  • (6) Cat. SBAOCRBEN8 - Lot #920306
  • Exp. 6/1/2024
  • UDI-DI 10195594882334
  • (7) Cat. SBA30MJCHH - Lot #937398
  • Exp. 4/1/2025

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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