BD PhaSeal 515307Recalls & reported problems
BD Switzerland Sàrl · INFUSION ADAPTER C100 MULTI · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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 00382905153075), received between Oct 22, 2021 and Oct 22, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 16, 2025Open, Classified
Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
Z-2453-2025 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
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.
MalfunctionOct 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BD PHASEAL¿ INFUSION ADAPTER HAD AN ISSUE WITH FOREIGN MATERIAL/CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOW THEY REALIZED WHITE FLUFFY PARTICLES AND ONE GREY PARTICLE IN READY DRUG BAG AFTER USED PHASEAL SYSTEM:PROTECTOR, INJECTOR AND ADAPTER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12682847 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.