CARDINAL HEALTH 03-8909DRecalls & reported problems
Cardinal Health 200, LLC · CENTRAL LINE DRESSING KIT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 2
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888439921847), received between Feb 26, 2022 and Feb 26, 2022 — classified as 2 deaths, 3 injuries.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 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
Device problems
- No Apparent Adverse Event5
- Manufacturing, Packaging or Shipping Problem2
- Adverse Event Without Identified Device or Use Problem1
- Output Problem1
- Patient-Device Incompatibility1
Patient problems
- Insufficient Information5
- Unspecified Infection5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
DeathFeb 26, 2022Patient-Device Incompatibility; No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER BELIEVES THAT THEY DID NOT PREVIOUSLY APPROVE A CHANGE IN THE DRESSING COMPONENT IN THEIR CUSTOM KIT FROM A MEDLINE PRODUCT (SVUD73AFQB) TO A 3M TEGADERM. WHILE THE CUSTOMER IS NOT SAYING DEFINITIVELY THAT THE 3M TEGADERM DRESSING SUBSTITUTION WAS THE CAUSE OF THE INCREASE IN CLABSI, THEY BELIEVE IT IS LIKELY A CONTRIBUTING FACTOR FOR THE INCREASE IN CLASBI INFECTIONS AT THE FACILITY. THE COMPLAINT DID NOT IDENTIFY ANY DEFECTS OR DEFICIENCIES WITH THE KIT OR COMPONENTS.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 13608161 ↗InjuryFeb 26, 2022Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER BELIEVES THAT THEY DID NOT PREVIOUSLY APPROVE A CHANGE IN THE DRESSING COMPONENT IN THEIR CUSTOM KIT FROM A MEDLINE PRODUCT (SVUD73AFQB) TO A 3M TEGADERM. WHILE THE CUSTOMER IS NOT SAYING DEFINITIVELY THAT THE 3M TEGADERM DRESSING SUBSTITUTION WAS THE CAUSE OF THE INCREASE IN CLABSI, THEY BELIEVE IT IS LIKELY A CONTRIBUTING FACTOR FOR THE INCREASE IN CLASBI INFECTIONS AT THE FACILITY. THE COMPLAINT DID NOT IDENTIFY ANY DEFECTS OR DEFICIENCIES WITH THE KIT OR COMPONENTS.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 13608123 ↗InjuryFeb 26, 2022Output Problem; No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER BELIEVES THAT THEY DID NOT PREVIOUSLY APPROVE A CHANGE IN THE DRESSING COMPONENT IN THEIR CUSTOM KIT FROM A MEDLINE PRODUCT (SVUD73AFQB) TO A 3M TEGADERM. WHILE THE CUSTOMER IS NOT SAYING DEFINITIVELY THAT THE 3M TEGADERM DRESSING SUBSTITUTION WAS THE CAUSE OF THE INCREASE IN CLABSI, THEY BELIEVE IT IS LIKELY A CONTRIBUTING FACTOR FOR THE INCREASE IN CLASBI INFECTIONS AT THE FACILITY. THE COMPLAINT DID NOT IDENTIFY ANY DEFECTS OR DEFICIENCIES WITH THE KIT OR COMPONENTS.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 13608119 ↗DeathFeb 26, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER BELIEVES THAT THEY DID NOT PREVIOUSLY APPROVE A CHANGE IN THE DRESSING COMPONENT IN THEIR CUSTOM KIT FROM A MEDLINE PRODUCT ((B)(4)) TO A 3M TEGADERM. WHILE THE CUSTOMER IS NOT SAYING DEFINITIVELY THAT THE 3M TEGADERM DRESSING SUBSTITUTION WAS THE CAUSE OF THE INCREASE IN CLABSI, THEY BELIEVE IT IS LIKELY A CONTRIBUTING FACTOR FOR THE INCREASE IN CLASBI INFECTIONS AT THE FACILITY. THE COMPLAINT DID NOT IDENTIFY ANY DEFECTS OR DEFICIENCIES WITH THE KIT OR COMPONENTS.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 13608114 ↗InjuryFeb 26, 2022Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER BELIEVES THAT THEY DID NOT PREVIOUSLY APPROVE A CHANGE IN THE DRESSING COMPONENT IN THEIR CUSTOM KIT FROM A MEDLINE PRODUCT (SVUD73AFQB) TO A 3M TEGADERM. WHILE THE CUSTOMER IS NOT SAYING DEFINITIVELY THAT THE 3M TEGADERM DRESSING SUBSTITUTION WAS THE CAUSE OF THE INCREASE IN CLABSI, THEY BELIEVE IT IS LIKELY A CONTRIBUTING FACTOR FOR THE INCREASE IN CLASBI INFECTIONS AT THE FACILITY. THE COMPLAINT DID NOT IDENTIFY ANY DEFECTS OR DEFICIENCIES WITH THE KIT OR COMPONENTS.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 13608113 ↗
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- MEDLINE EBSI1382Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DM1035ACenturion Medical Products Corporation · Dressing change tray2 recalls0 reports
- MEDLINE EBSI1464Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DT8670ACenturion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion Medical Products Corp DT22065Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- MEDLINE EBSI1498Medline Industries, Inc. · Dressing change tray2 recalls0 reports
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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