CARDINAL HEALTH SAN21HCNSCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439824247), received between Jun 28, 2022 and Sep 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2022Material Separation; Material Separation

  BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD (DHR) REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.178G/10PCS. THIS IS A SINGLE USE PRODUCT. A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. A PHOTO WAS PROVIDED WHICH SHOWED BLUE LINT ON GLOVES. ACCORDING TO THE SUPPLIER, THE OR TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: A. SUCTION MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS, B. THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE (SOP) REQUIREMENT, C. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10PIECES), D. IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. FROM THE INVESTIGATION, NO ABNORMAL SITUATION HAPPENED IN PRODUCTION OR DHR. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407475 ↗
• MalfunctionJul 1, 2022Material Separation; Material Separation

  CUSTOMER REPORTED THE BLUE TOWELS (PWTB04-STM) IN THEIR HEART CATH PACK (SAN21HCNSC ) WERE SHEDDING DURING INTRAVASCULAR ULTRASOUND(IVUS) PROCEDURE. REPORTEDLY, DR. DUPONT FOUND SOME OF THE SHREDDED FIBERS ON THE CATHETER AND PATIENT. NO KNOWN ADVERSE IMPACTS TO PATIENT. NO PATIENT DEMOGRAPHICS OR OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885444 ↗
• MalfunctionJun 28, 2022Material Separation; Material Separation

  CUSTOMER REPORTED AN ABUNDANCE OF SHEDDING OF THE BLUE COTTON OR TOWELS, PWTB04-STM, FROM THE HEART CATH PACK, SAN21HCNSC. NO INJURY WAS REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842637 ↗