Alaris 2206-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Yellow-Striped Microbore Tubing 248 cm (98 in) · Class 2
All models of Alaris (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name 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
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613203019224), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
2 FDA recall records name this device's 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, 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
- Aug 19, 2026Class IOpen, Classified
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Oct 11, 2023Class IIOpen, Classified
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Z-0349-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Infusion or Flow Problem1
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.
MalfunctionFeb 19, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE YELLOW STRIPED MICROBORE INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SET BEING USED VIA GRAVITY, INFUSION SET VERY SLOW AND INFUSION RATE COULDN'T BE ACHIEVED. SLOWNESS OF INFUSION FLOW WILL AFFECT THE RESULT WHICH HAS TO BE ACHIEVED FOR THE PATIENT. THE TIME CONSUMES FOR THE WHOLE PROCEDURE WILL RESULTS IN PATIENT DISSATISFACTION AS WELL. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IF IT IS NOT POSSIBLE TO RETURN THE AFFECTED PRODUCT, PLEASE PROVIDE DETAILED PHOTOGRAPHS OF THE PRODUCT(S) AND THE DAMAGED AREA(S)? YES. PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED? 64. PLEASE CONFIRM HOW THE FAULT WAS IDENTIFIED? WHILE DOING PROCEDURE (IV INFUSION). PLEASE CONFIRM WHEN THE FAULT WAS IDENTIFIED DURING PRIMING OR DURING INFUSION? IF DURING INFUSION, HOW LONG INTO THE INFUSION? PRIMING AS WELL AS INFUSION. PLEASE CONFIRM THE INFUSION SET-UP ¿ GRAVITY OR PUMP, HEIGHT OF INFUSION LINE, ENTRY POINT TO PATIENT, INFUSION RATE AND PRESSURE, INFUSION LINE SET-UP (OTHER EXTENSIONS OR ACCESSORIES) ETC? WITH PUMP NO ISSUES, THE ISSUE OCCURS WITH GRAVITY. PLEASE CONFIRM THE MAKE AND MODEL OF T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21415080 ↗
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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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