CARDINAL HEALTH SUT13SBMGARecalls & reported problems
Cardinal Health 200, LLC · STERILE SINGLE BASIN PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488644226), received between Nov 8, 2018 and Nov 8, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Disintegration” (1 report).
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
Device problems
- Material Disintegration1
- Product Quality Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2018Material Disintegration; Product Quality Problem
MD REGARDING SIGNIFICANT CONCERNS REGARDING LINT/THREAD/DEBRIS SHEDDING FROM THE NEW BLUE STERILE TOWELS. THE NEW BLUE TOWELS LEAVE A LOT OF DEBRIS. THIS IS A SIGNIFICANT STROKE/EMBOLIC RISK DURING NEURO ENDOVASCULAR PROCEDURES. WE HAVE SINCE TESTED THE FOLLOWING CARDINAL ITEMS: TWO PACKS OF DISPOSABLE TOWELS WITH DIFFERENT LOT NUMBERS 180525-16-SH/180322-16-SH (CAT# 28700-004, BAR CODE: ((B)(4)). BLUE DISPOSABLE TOWEL FROM SINGLE BASIN CUSTOM PACK LOT # 963391( CAT # SUT13SBMGA, BAR CODE: ((B)(4)). BLUE DISPOSABLE TOWEL FROM MAJOR BASIN CUSTOM PACK LOT # 980587 (CAT # SUT13BMMGA BAR CODE: ((B)(4)). WITH AND WITHOUT AGITATION. SOAKING IN STERILE SALINE. SOAKING IN STERILE WATER . WE FOUND LINT/DEBRIS IN EVERY TEST, THE MOST SIGNIFICANT AMOUNT OF DEBRIS WE WERE ABLE TO VISUALIZE WAS IN THE TOWEL THAT WAS SOAKING. THE CARDINAL REPS WERE IN HOUSE AND WE NOTIFIED THEM AND SENT THEM THE TEST RESULTS FOR INTERNAL QA REVIEW. TESTED ANOTHER MANUFACTURER GREEN RF OR TOWELS. AGAIN TESTED WITH AND WITHOUT AGITATION, DRY AND THEN SOAKING IN STERILE SALINE. DEBRIS WAS PRESENT , APPEARED LESS THAN THE ABOVE CARDINAL ITEMS. MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, CARDINAL HEALTH (PER SITE
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8050544 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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