The Recall Desk

FDA (Devices) recall action 92875

Cardinal Health 200, LLC recalled 10 products on 2023-10-18

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products
10
Announced
2023-10-18
Critical
0
Units
133,510

Why these products were recalled

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

XXX

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs With Recalled Components

    Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.

    Product
    Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2023-10-18

    Medical Procedure Packs Recalled Due to Defective Components

    Cardinal Health is recalling surgical procedure packs due to defective components. The recall affects 13,351 packs distributed across the US and Canada.

    Product
    Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, Sterile.
    Category
    Distribution
    34 states
  • ModerateFDA (Devices)··2023-10-18

    Cardinal Health recalls procedure packs containing defective components

    Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs (Lot #967679) containing defective equipment drapes, table covers, and surgical room turnover kits distributed nationwide and in Canada.

    Product
    Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs Due to Defective Components

    Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide and in Canada. The packs contain recalled equipment drapes, table covers, and surgical room turnover kits.

    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) Presour
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2023-10-18

    Cardinal Health procedure packs recalled for containing previously recalled components

    Cardinal Health is recalling surgical procedure packs that contain previously recalled components including equipment drapes, table covers, and surgical room turnover kits. Approximately 13,351 packs were distributed nationwide and in Canada.

    Product
    Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
    Category
    Distribution
    34 states
  • ModerateFDA (Devices)··2023-10-18

    Presource PBDS Surgical Procedure Packs Subject to Nationwide Recall

    Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs distributed nationwide in the US and Canada. The specific reason for the recall was not disclosed in the available FDA notice.

    Product
    Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5
    Category
    Distribution
    34 states
  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2023-10-18

    Cardinal Health recalls Presource Fistulogram Packs with defective components

    Cardinal Health is recalling Presource Fistulogram Packs containing recalled components including equipment drapes and table covers. Approximately 13,351 sterile packs distributed across 33 US states and Canada are affected.

    Product
    Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2023-10-18

    Surgical procedure packs containing recalled equipment components distributed nationwide

    Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide that contain recalled components including equipment drapes and table covers.

    Product
    Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robo
    Category
    Distribution
    34 states