OnGuard®2 CSTD Syringe Adaptor 412163Recalls & reported problems
Simplivia Healthcare Ltd · OnGuard®2 CSTD Syringe Adaptor A Chemfort CSTD Product · Class 2
Data updated Oct 18, 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 27290115921636), received between Apr 3, 2023 and Apr 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 other recall cover devices cleared under the same FDA submission (K192866); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Fluid/Blood Leak1
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.
MalfunctionApr 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE 412163 CAME LOOSE CAUSING AN OPEN CONNECTION. THE PATIENT BLED ON HIMSELF WHILE FAMILY WAS PRESENT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16662556 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192866. One submission often covers many models, so check the product and lot details in each record.
- Z-1057-2022 · Mar 8, 2022 · Open, ClassifiedOnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Other Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System devices
- BD PhaSeal 515003BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall183 reports
- BD PhaSeal 515056BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall159 reports
- BD PhaSeal Optima 515070BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall154 reports
- Alaris 10012241-0500BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall138 reports
- BD PhaSeal 515005BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall128 reports
- ICU Medical CL3011Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls26 reports
- BD PhaSeal Optima 515052BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall114 reports
- ICU Medical CL3511Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system3 recalls6 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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