Safe-T-CentesisRecalls & reported problems across all models
Carefusion 2200, Inc · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Safe-T-Centesis model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 217
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 7
We found 7 models of Safe-T-Centesis by Carefusion 2200, Inc in the FDA's device registry (GUDID). Together they are named in 217 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2020 and Sep 22, 2026 — classified as 13 injuries, 204 malfunctions.
The most frequently reported specific device problem is “Contamination” (168 reports).
7 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Safe-T-Centesis recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 6, 2025Open, Classified
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Z-0887-2026 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2022Open, 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 ↗
- May 28, 2020Terminated
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2652-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 28, 2020Terminated
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2651-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 28, 2020Terminated
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2650-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 28, 2020Terminated
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2649-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 28, 2020Terminated
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2648-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Safe-T-Centesis problems
Device problems
- Contamination168
- Gas/Air Leak9
- Complete Blockage7
- Break5
- Device Markings/Labelling Problem5
- Image Orientation Incorrect4
- Leak/Splash4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions201
- Pneumothorax7
- Insufficient Information5
- Laceration(s)2
- Needle Stick/Puncture2
- Discomfort1
- No Consequences Or Impact To Patient1
Safe-T-Centesis models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Safe-T-Centesis PIG1260TThoracentesis tray2 recalls27 reports
- Safe-T-Centesis PIG1260KThoracentesis tray1 recall73 reports
- Safe-T-Centesis PIG1280KThoracentesis tray108 reports
- Safe-T-Centesis PIG1280TThoracentesis tray1 recall8 reports
- Safe-T-Centesis PIG1280TSPThoracentesis tray1 recall1 report
- Safe-T-Centesis PIG1260TSPThoracentesis tray1 recall0 reports
- Safe-T-Centesis PIG1260TCDFThoracentesis tray1 recall0 reports
Recent Safe-T-Centesis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862899 ↗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 ↗
Other Carefusion 2200, Inc products
All Carefusion 2200, Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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