FDA Device Intelligence
Home › ICU MEDICAL, INC. › ICU Medical

ICU Medical

ICU MEDICAL, INC. · Model CL-51-10 · UDI-DI 00887709123151

ONB Prescription
1
510(k) clearances
4,837
Adverse events
73
Recalls
41
Facilities

Description

ChemoLock™ Port, Vented Vial Spike, 10 Units

Recalls

DateFirmReason
2026-05-12ICU Medical, Inc.Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-05-12ICU Medical, Inc.Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-03-24ICU Medical, Inc.Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.