Safe-T-Centesis PIG1280TSPRecalls & reported problems
Carefusion 2200, Inc · Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray · Class 2
All models of Safe-T-Centesis (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403108426), received between Mar 4, 2022 and Mar 4, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- May 28, 2020Class IITerminated
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 ↗
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2022Break; Break
IT WAS REPORTED NEEDLE HAS DETACHED. VERBATIM: NEEDLE PORTION HAS DETACHED. THE NUMBING BD SAFETY GLIDE NEEDLES IN THIS KIT ARE EXTREMELY FLIMSY AND HAVE BROKEN OFF INTO PATIENTS UPON INSERTION ON THREE DIFFERENT OCCASIONS. (THEY WERE EASILY PULLED OUT AND NO PATIENT HARM DONE) BOTH THE 25G X 1¿ AND THE 22G X 1.5¿ ARE HAVING THE SAME ISSUE AND ARE VERY DANGEROUS. PROVIDERS ARE REQUESTING DIFFERENT KITS. STAFF HAVE NOTICED LAXITY OF THE 25 GAUGE NEEDLE IN THE SAFE-T-CENTESIS KITS, TO THE POINT WHERE THE NEEDLE PORTION HAS DETACHED FROM THE REST OF THE APPARATUS. WHILE THERE HAS NOT BEEN PATIENT HARM, THIS IS A SAFETY CONCERN AS A NEEDLE MIGHT DETACH AND BE LOST INSIDE OF A PATIENT (THESE KITS ARE TYPICALLY USED FOR PARACENTESIS AND THORACENTESIS). THIS ISSUE HAS BEEN NOTED WHEN USING THESE KITS MULTIPLE TIMES OVER THE PAST WEEK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13671711 ↗
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
- 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
- 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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