Hospira 1269402Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD Primary Blood Set 200 Micron Filter, Prepierced Y-Site, Secure Lock, 80 Inch · Class 2
All models of Hospira (5)
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 10887787008811), received between May 3, 2024 and May 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
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
Most reported problems
Device problems
- Air/Gas in Device1
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.
MalfunctionMay 3, 2024Air/Gas in Device; Air/Gas in Device
THE EVENT INVOLVED A PRIMARY BLOOD SET, 200 MICRON FILTER, PRE PIERCED Y-SITE, SECURE LOCK, 80 INCH WHERE IT WAS REPORTED THAT THE BLOOD ADMINISTRATION SET WAS THROWING AIR BUBBLES. DEVICE WAS DISCARDED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19239942 ↗
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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
- 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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