CAP CAP8-U8CAP-LG_XLRecalls & reported problems
Burlington Medical, LLC · Cap - Standard Size with Drawstring Toggle Closure, .25mm Xneolite 800 NL Size Small / Medium, CAP8-U8CAP-LG_XL · Class 1
All models of CAP (8)
Data updated Oct 16, 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 00840186696457), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Connection Problem; Connection Problem
ACCORDING TO THE REPORTER, THE CAP FOR THE TRACHEOSTOMY TUBE WAS NOT SECURING TO THE 15-MM CONNECTOR, EVEN AFTER A ONE-FOURTH TURN HAD BEEN COMPLETED, AND APPEARED LOOSE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 19639224 ↗
Other Apron, Protective devices
- DHALF R8DHALFR-SBurlington Medical, LLC · Apron, Protective1 recall0 reports
- F01 S8F01*FBurlington Medical, LLC · Apron, Protective1 recall0 reports
- FVEST R8FVEST-XLFBurlington Medical, LLC · Apron, Protective1 recall0 reports
- HALF APRON R8HALF3HBurlington Medical, LLC · Apron, Protective1 recall0 reports
- K303 S8K303-MMBurlington Medical, LLC · Apron, Protective1 recall0 reports
- FVEST S8FVEST-XLFBurlington Medical, LLC · Apron, Protective1 recall0 reports
- KILT R8KILT-LFBurlington Medical, LLC · Apron, Protective1 recall0 reports
- KILT BLOCKER U8KILTBLOCKER18X20Burlington Medical, LLC · Apron, Protective1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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