Agency classClass IIOur severity:High FDA (Devices)·Z-1682-2022·Announced 2022-09-14

ChemoLock Chemotherapy Port Connectors Recalled for Disconnection Risk

ICU Medical recalls ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to spring defects that may prevent proper connection or cause unintended disconnection, potentially delaying treatment or exposing patients to caustic substances.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 an FDA Class II recall of a chemotherapy delivery device with a confirmed spring defect that can cause disconnection or connection failure. While no injuries or illnesses have been reported, the potential for treatment delays and caustic chemotherapy exposure creates high-risk harm potential without confirmed adverse events.

Plain-English summary

ICU Medical, Inc. is recalling ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to a defect in the spring mechanism. Approximately 358,975 units have been affected.

The ports function as standalone connectors or as integrated access points on vial adapters, bag spikes, and administration sets. A variation in the internal spring may cause unintended disconnection, inability to connect, or failure to fully engage with injectors. These failures could delay cancer therapy or potentially expose patients to caustic chemotherapy substances.

The recalled products were distributed worldwide, including throughout the United States and internationally in Saudi Arabia, Australia, United Arab Emirates, Spain, Slovenia, Japan, and Canada. The FDA and manufacturer have provided specific product codes and lot numbers for affected units.

Healthcare providers should verify that ChemoLock and ChemosafeLock components in their facilities are not affected and contact ICU Medical with questions regarding specific products.

The recalled product

Product: Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Chemotherapy Delivery / Drug Administration
Hazard: disconnection
connection-failure
caustic-exposure
Affected units: 358,975

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)

OUS Distributed Only Item/Lots: 011-CL-80S/5843950
CL-10/5850516
CL-17/5816314
5829878
5842209
5850503
CL3950/5845117
5885020
CL3951/5842199
5872831
CL3967/5829901
5842210
CL4118/5825274
5872840
KL-BS001U3/5851020
5851021
5851022
5910255
5910258
KL-VA201U3/5819364

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 →

Same manufacturer · ICU Medical, Inc.

See all →

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Same hazard · disconnection