Cardinal Health 200, LLC: Device Recall

Recall Details

Recall Number

Z-1133-2025

Classification

Class II

Product Type

Device

Recalling Firm

Cardinal Health 200, LLC

Status

Ongoing

Date Initiated

11/08/2024

Location

Waukegan, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

973,785 total units

Reason for Recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Product Description

Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Other Recalls by Cardinal Health 200, LLC

• Class II: Risk 12/26/2025
  The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
• Class II: Risk 11/12/2025
  Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
• Class II: Risk 09/18/2025
  Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
• Class II: Risk 09/18/2025
  Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
• Class II: Risk 09/18/2025
  Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

View all recalls by Cardinal Health 200, LLC →