Safe-T-Centesis PIG1260KRecalls & reported problems
Carefusion 2200, Inc · Safe-T-Centesis 6Fr 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 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 73
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10885403076114), received between Jun 23, 2021 and Sep 12, 2026 — classified as 73 malfunctions.
The most frequently reported specific device problem is “Contamination” (69 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Apr 22, 2022Class IIOpen, Classified
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.
Z-1273-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination69
- Device Markings/Labelling Problem1
- Difficult to Insert1
- Fluid/Blood Leak1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions73
Recent adverse event reports
The 25 most recent of 73 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 50744946 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744945 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744944 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744943 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744941 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744940 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744939 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744938 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744937 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744936 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744935 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744933 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744932 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744931 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744929 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744928 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744926 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744925 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744924 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744923 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744921 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744918 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744917 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744839 ↗MalfunctionSep 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744838 ↗
Other Thoracentesis tray devices
- Safe-T-Centesis PIG1260TCarefusion 2200, Inc · Thoracentesis tray2 recalls27 reports
- NA OTP5000Carefusion 2200, Inc · Thoracentesis tray2 recalls13 reports
- Safe-T-Centesis PIG1280KCarefusion 2200, Inc · Thoracentesis tray108 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
- Safe-T-Centesis PIG1280TSPCarefusion 2200, Inc · Thoracentesis tray1 recall1 report
- NA TPT1005Carefusion 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 · each recall links to the FDA recall notice
- 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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