Medline Industries, Inc. LC435Recalls & reported problems
Medline Industries, Inc. · LIPID LINE EXCHANGE KIT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489455557), received between Aug 19, 2021 and Aug 19, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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
- Microbial Contamination of Device1
Patient problems
- Bacterial Infection1
- Viral Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2021Microbial Contamination of Device
IT WAS REPORTED, "THREE CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSIS) HAVE OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT (NICU) SINCE THE START OF THE TUBING KIT ROLLOUT ON (B)(6) 2021." LATER EMAIL CONFIRMED POSITIVE BLOOD CULTURE DATES AS, (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021.
Patient problems: Bacterial Infection; Viral Infection
MAUDE report 12343395 ↗
Other Central venous catheter tray devices
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- Medline Industries, Inc. DYNJ55546DMedline Industries, Inc. · Central venous catheter tray3 recalls0 reports
- Medline Industries, Inc. DYNJ68037CMedline Industries, Inc. · Central venous catheter tray2 recalls1 report
- Medline Industries, Inc. DYNJ84239Medline Industries, Inc. · Central venous catheter 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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