ICU Medical 13814-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709065383), received between Nov 9, 2018 and Nov 9, 2018 — classified as 1 malfunction.

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

7 other recalls cover devices cleared under the same FDA submission (K081361); 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.

• MalfunctionNov 9, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CUSTOMER REPORT OF A CHEMOTHERAPY SPILL OF VINCRISTINE WHEN THE SPIKE OF THE CHEMOCLAVE BAG SPIKE CAME OUT OF THE DRY PORT DURING "CIRCUM PRIMING". IT WAS REPORTED THAT THE FACILITY PRACTICES "CIRCUM PRIMING" WHERE INSTEAD OF USING NORMAL SALINE FOR PRIMING (SINCE IT TAKES A WHILE FOR THE CHEMO DRUG TO REACH TO A PATIENT), A CHEMO DRUG WAS USED. THE DRY SPIKE IS HOOKED TO THE CHEMO TUBING AND AUTOMATICALLY STARTS PRIMING. ONCE DONE, THE CHEMO TUBING IS HOOKED TO A PATIENT. THIS EVENT HAPPENED AFTER THE PHARMACY SPIKED THE BAG AND ADDED THE DRUG TO THE BAG. THE NURSE WAS GETTING THE BAG SET UP TO INFUSE WHEN THE SPIKE CAME OFF CAUSING THE SPILL. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION PROVIDED AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 8055992 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081361. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3158-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-1565-2021 · Mar 16, 2021 · Open, Classified
  REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medicatio
• Z-1566-2021 · Mar 16, 2021 · Open, Classified
  REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications
• Z-0701-2021 · Aug 31, 2020 · Open, Classified
  5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (1
• Z-1093-2019 · Feb 21, 2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanical
• Z-1092-2019 · Feb 21, 2019 · Terminated
  icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanica