The Recall Desk
HighFDA (Devices)·Z-0335-2026·Announced 2025-11-05

Bag spikes with Clave additive port recalled over port weld separation

ICU Medical is recalling 3,000 ChemoLock Bag Spikes with Clave additive 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 ChemoLock Bag Spike with Clave Additive Port, REF CL3940, 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 3,000 units carrying UDI 10887709095295, from lot 14406773. 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 spikes are used to transfer hazardous drugs, facilities should quarantine the affected lot and follow ICU Medical's instructions.

The recalled product

Product
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
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:10887709095295/Lot: 14406773

Distribution

Distributed nationwide across the United States.

Related recalls

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