The Recall Desk
HighFDA (Devices)·Z-0353-2026·Announced 2025-11-05

Bag spikes with additive port recalled over port weld separation risk

ICU Medical is recalling 6,450 6.5-inch bag spikes with ChemoLock 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 6.5 inch bag spike with ChemoLock port additive port and ChemoLock port, REF CL3955, 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 6,450 units carrying UDI 10887709071411, from lots 14386086 and 14407433. 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 affected lots and follow ICU Medical's instructions.

The recalled product

Product
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
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:10887709071411/Lot:14386086 14407433

Distribution

Distributed nationwide across the United States.

Related recalls

Same category