The Recall Desk
HighFDA (Devices)·Z-0351-2026·Announced 2025-11-05

21 inch extension sets recalled over port weld separation risk

ICU Medical is recalling 950 21-inch extension sets with ChemoLock port 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 21 inch extension set with ChemoLock port, clamp and graduated connector, REF CL3360, 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 10887709071398, from lots 14397348 and 14377757. 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 affected lots and follow ICU Medical's instructions.

The recalled product

Product
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
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 (2)

  • UDI:10887709071398/Lot:14397348
  • 14377757

Distribution

Distributed nationwide across the United States.

Related recalls

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