Lifeshield 1266128Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887787005636), received between Sep 12, 2023 and Sep 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Free or Unrestricted Flow” (5 reports).

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

1. May 12, 2026Open, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3160-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2023Free or Unrestricted Flow; Free or Unrestricted Flow

  THE EVENT INVOLVED A PRIMARY SET, 1 CLAVE Y-SITE, SECURE LOCK, 100 INCH WHERE IT WAS REPORTED MALFUNCTION/UNSTABLE DROP CONTINUE REGULATOR. THE EVENT WAS NOTED DURING USE IN PATIENT. PRODUCT FAILURE WAS AT THE CLAMP. NO MEDICAL INTERVENTION AND NO BLOOD LOSS. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY. THIS IS THE FIFTH OF FIVE OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732354 ↗
• MalfunctionSep 12, 2023Free or Unrestricted Flow; Free or Unrestricted Flow

  THE EVENT INVOLVED A PRIMARY SET, 1 CLAVE Y-SITE, SECURE LOCK, 100 INCH WHERE IT WAS REPORTED MALFUNCTION/UNSTABLE DROP CONTINUE REGULATOR. THE EVENT WAS NOTED DURING USE IN PATIENT. PRODUCT FAILURE WAS AT THE CLAMP. NO MEDICAL INTERVENTION AND NO BLOOD LOSS. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY. THIS IS THE FORTH OF FIVE OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732329 ↗
• MalfunctionSep 12, 2023Free or Unrestricted Flow; Free or Unrestricted Flow

  THE EVENT INVOLVED A PRIMARY SET, 1 CLAVE Y-SITE, SECURE LOCK, 100 INCH WHERE IT WAS REPORTED MALFUNCTION/UNSTABLE DROP CONTINUE REGULATOR. THE EVENT WAS NOTED DURING USE IN PATIENT. PRODUCT FAILURE WAS AT THE CLAMP. NO MEDICAL INTERVENTION AND NO BLOOD LOSS. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY. THIS IS THE THIRD OF FIVE OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732313 ↗
• MalfunctionSep 12, 2023Free or Unrestricted Flow; Free or Unrestricted Flow

  THE EVENT INVOLVED A PRIMARY SET, 1 CLAVE Y-SITE, SECURE LOCK, 100 INCH WHERE IT WAS REPORTED MALFUNCTION/UNSTABLE DROP CONTINUE REGULATOR. THE EVENT WAS NOTED DURING USE IN PATIENT. PRODUCT FAILURE WAS AT THE CLAMP. NO MEDICAL INTERVENTION AND NO BLOOD LOSS. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY. THIS IS THE SECOND OF FIVE OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732283 ↗
• MalfunctionSep 12, 2023Free or Unrestricted Flow; Free or Unrestricted Flow

  THE EVENT INVOLVED A PRIMARY SET, 1 CLAVE Y-SITE, SECURE LOCK, 100 INCH WHERE IT WAS REPORTED MALFUNCTION/UNSTABLE DROP CONTINUE REGULATOR. THE EVENT WAS NOTED DURING USE IN PATIENT. PRODUCT FAILURE WAS AT THE CLAMP. NO MEDICAL INTERVENTION AND NO BLOOD LOSS. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY. THIS IS THE FIRST OF FIVE OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732201 ↗