ICU Medical recalls ChemoLock vial spikes and bag spikes due to potential unintended disconnection, which may delay therapy and cause exposure to caustic substances. Affected products include specific models and lots.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
ICU Medical is recalling several types of ChemoLock vial spikes and bag spikes because a variation in the spring inside the port can cause unintended disconnection. This may delay cancer treatment and expose patients to harmful chemicals.
The spring variation in the port can cause the spike to disconnect unexpectedly. This may delay cancer treatment and expose patients to caustic substances if the connection is not properly maintained.
Patients receiving chemotherapy through these devices are most at risk. Healthcare providers using the products for medical treatments may also be affected.
Check for product names like 'ChemoLock Vial Spike', 'ChemoLock Bag Spike', or 'ChemoLock w/Mini Bag'. Look for model numbers such as 011-CL-80S, CL-10, or CL-17. Products were sold with specific lots and quantities listed in the recall notice.
Identify the model number on the product, such as 011-CL-80S, CL-10, or CL-17, to determine if it is affected.
Reach out to ICU Medical directly for assistance with the recall and to confirm if your product is affected.
Affected products include ChemoLock Vial Spikes (20mm/011-CL-80S), ChemoLock Bag Spikes (CL-10), and ChemoLock w/Mini Bag (CL-17), among others with specific model numbers and lots listed in the recall notice.
The recall is due to a potential variation in the spring inside the port that can cause unintended disconnection, which may delay cancer treatment and expose patients to caustic substances.
Check the model number on the product, such as 011-CL-80S, CL-10, or CL-17. Products were sold with specific lots and quantities listed in the recall notice.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1682-2022 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1682-2022 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
