Safe-T-Centesis PIG1280KRecalls & reported problems
Carefusion 2200, Inc · Safe-T-Centesis 8Fr Catheter Drainage Kit - Safe-T-Centesis Catheter Drainage Device, Extension Set, Scalpel, Vacuum Needle, and Sharps Engineered Safety Device · Class 2
All models of Safe-T-Centesis (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This CareFusion thoracentesis drainage kit is used to drain fluid from the chest. Reports mostly describe foreign material found in unopened packages, color indicators or labeling that did not read correctly, and catheters or connections that blocked, leaked or came loose, including 2 mentions of pneumothorax. There are 26 adverse event reports, including 3 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 108
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10885403076107), received between Jun 14, 2022 and Sep 12, 2026 — classified as 3 injuries, 105 malfunctions.
The most frequently reported specific device problem is “Contamination” (95 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination95
- Image Orientation Incorrect4
- Device Markings/Labelling Problem3
- Complete Blockage2
- Retraction Problem2
- Detachment of Device or Device Component1
- Difficult to Remove1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions105
- Pneumothorax2
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744987 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744986 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744985 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744984 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744983 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744982 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744981 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744980 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744979 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744978 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744977 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744976 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744975 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744974 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744973 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744972 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744971 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744970 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744968 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744967 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744966 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744965 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744964 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744963 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744962 ↗
Other Thoracentesis tray devices
- Safe-T-Centesis PIG1260TCarefusion 2200, Inc · Thoracentesis tray2 recalls27 reports
- Safe-T-Centesis PIG1260KCarefusion 2200, Inc · Thoracentesis tray1 recall73 reports
- NA OTP5000Carefusion 2200, Inc · Thoracentesis tray2 recalls13 reports
- NA TPT1000Carefusion 2200, Inc · Thoracentesis tray1 recall1 death19 reports
- Safe-T-Centesis PIG1280TCarefusion 2200, Inc · Thoracentesis tray1 recall8 reports
- Safe-T TPT1000SPCarefusion 2200, Inc · Thoracentesis tray1 recall6 reports
- NA TPT1005Carefusion 2200, Inc · Thoracentesis tray1 recall1 report
- Safe-T-Centesis PIG1280TSPCarefusion 2200, Inc · Thoracentesis tray1 recall1 report
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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