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.
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 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…
- Manufacturer
- ICU Medical, Inc.
- 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
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.
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