Lifeshield 1421728Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD, Primary Y-Type Blood Set, 200 Micron Filter, Prepierced Y-Site, Secure Lock, 80 Inch · Class 2
- 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 10887787006435), received between Nov 4, 2024 and Nov 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Flow” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Flow1
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.
MalfunctionNov 4, 2024No Flow; No Flow
A COMPLAINT WAS RECEIVED INVOLVING A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, PREPIERCED Y-SITE, SECURE LOCK, 80 INCH EXPERIENCED OCCLUSION. IT WAS REPORTED THAT THE BLOOD TUBING FILTER WAS PREVENTING/FILTERING THE ADMINISTRATION OF ANTIBIOTICS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT. ADDITIONAL INFORMATION: IV ANTIBIOTICS, IV TYNENOL, ALBUMIN, ETC ARE FREQUENTLY USED WITH THE TUBING WHILE NORMAL SALINE OR SIMILAR FLUID IS ON THE OTHER PORTION OF THE Y.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20603303 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.