The Recall Desk
HighFDA (Devices)·Z-0338-2026·Announced 2025-11-05

Anti-siphon smallbore extension sets recalled over port weld separation risk

ICU Medical is recalling 950 45-inch smallbore extension sets with an anti-siphon valve because the port weld of the drug transfer device may separate or break during use and leak.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: a weld that can break and leak on a drug transfer device is a hazard, and no injuries are reported.

Plain-English summary

The ICU Medical 45 inch (114 cm) approximately 1.7 mL smallbore extension set with Spiros with red cap, anti-siphon valve, clamp, Y-connector with ChemoLock port and rotating Luer, REF CL4151, is being recalled.

The port weld of the drug transfer device may separate or break during use and potentially result in a leak.

The recall covers 950 units carrying UDI 10887709098388, from lot 14400230. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.

The enforcement record describes the weld failure and reports no injuries. Because these sets are used to transfer hazardous drugs, facilities should quarantine the affected lot and follow ICU Medical's instructions.

The recalled product

Product
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Drug transfer device
Hazard
  • weld-failure
  • leak
  • drug-transfer
  • chemotherapy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI:10887709098388/Lot: 14400230

Distribution

Distributed nationwide across the United States.

Related recalls

Same category