ICU Medical Z7110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709035904), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K070532); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVING 25 UNITS OF SPIROS® CLOSED MALE LUER EXPERIENCED LEAKAGE. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: ¿WE HAVE TWO CASES OF LEAKS CONCERNING THE USE OF SPRIROS : LEAK AT THE SPRIROS - NEEDLE CONNECTION.¿ UPDATE : THE INCIDENT WAS NOTICED BY THE CARE NURSE, WHO NOTIFIED THE UNIT PHARMACIST. THE INCIDENT HAPPENED AT THE TIME OF CONNECTING THE SYRINGE AT THE START OF THE INFUSION: < 1ML OF MEDICATION. THE EVENT HAPPENED ON (B)(6) 2024. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. THE PATIENT WAS CONNECTED TO THE DEVICE BUT NO ADVERSE EVENT AND NO NEED OF MEDICAL INTERVENTION. THERE WAS A DELAY IN THERAPY. DESTRUCTION OF THE USED SYRINGE AND REPLACEMENT. THE MEDICATION INVOLVED IS DARATUMUMAB SC (ANTI CORPS - CD38 INHIBITORS). THERE WAS A REMANUFACTURING OF A NEW PREPARATION. THE MEDICATION WAS CHANGED. THE LEAK OCCURRED FROM THE START OF ADMINISTRATION. THE LEAK WAS NOT CLEANED UP ACCORDING TO THE FACILITY¿S PROTOCOL BECAUSE IT WAS A MINIMAL LEAK. NO VISIBLE DEFAULT ON THE DEVICE BEFORE USE. NO CUT, NO TEAR AND NO HOLE ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978436 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070532. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2021 · Aug 31, 2020 · Open, Classified
  42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, RE