The Recall Desk
HighFDA (Devices)·Z-1681-2022·Announced 2022-09-14

ChemoLock Infusion Ports Recalled for Unintended Disconnection Risk

ICU Medical recalls ChemoLock chemotherapy infusion ports for potential unintended disconnection due to spring variation, which may delay therapy and expose patients to caustic substances.

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: This is a risk-of-harm product (chemotherapy infusion system) where a real disconnection mechanism could delay critical therapy and expose patients to caustic chemotherapy agents. However, no illnesses or injuries have been reported, placing this at the High severity level rather than Severe.

Plain-English summary

ICU Medical is recalling ChemoLock ports used in chemotherapy infusion systems. The affected products include bag spikes, vial adaptors, administration sets, and related connector components, available as standalone units or integrated into infusion delivery systems under multiple model numbers.

The ports contain a spring mechanism designed to prevent accidental disconnection. A variation in this spring's specification may cause unintended disconnection from or inability to fully engage with injectors. This defect may delay chemotherapy administration and potentially expose patients to caustic chemotherapy agents.

The recall encompasses 454,635 units distributed worldwide, including all United States regions and shipments to Canada, Japan, Australia, Saudi Arabia, United Arab Emirates, Spain, and Slovenia.

The recalled product

Product
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Chemotherapy Infusion
Hazard
Affected units
454,635

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 (20)

  • Item/UDI-DI/Lots: CL-10-10/10887709071022/5872839
  • 5891255
  • CL-12/10887709056975/5819981
  • 5856055
  • 5873186
  • CL-13/10887709056982/5850811
  • CL2100/5797867
  • 5816334
  • 5829882
  • 5850510
  • CL2100-5/10887709122960/5754377
  • CL2100T/10887709099293/5816341
  • 5842229
  • 5850517
  • CL2150/10887709094670/5829900
  • 5850507
  • CL3011/10887709057019/5829885
  • 5842227
  • CL3364/10887709073408/5841261
  • 5850805

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 2 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

See all →

Same hazard · disconnection

See all →