ICU Medical recalls ChemoLock Bag Spikes due to potential unintended disconnection, which may delay therapy and cause exposure to caustic substances. Affected items include various models with specific lot numbers.
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 ChemoLock Bag Spikes that may disconnect unexpectedly, risking delays in treatment and exposure to harmful chemicals. This affects specific models sold with certain lot numbers.
The spikes have a variation in the internal spring that can cause unintended disconnection. This may lead to treatment delays and exposure to caustic substances if the spike disconnects during use.
Patients receiving chemotherapy treatments using these spikes are most at risk. Healthcare providers and caregivers who use the products daily are also affected.
Check for product models like ChemoLock Bag Spike (CL-10-10), ChemoLock BAG SPIKE w/ ADDITIVE PORT (CL-12), or ChemoLock Port (CL2100) with specific lot numbers listed in the recall notice.
Identify the model number (e.g., CL-10-10, CL-12) and lot number from the product label.
Reach out to ICU Medical directly for further instructions on how to handle the recalled items.
No, only specific models with the listed lot numbers are affected.
Check the model number and lot number on the product label against the list provided in the recall notice.
The recall does not require immediate discontinuation; however, you should check the model and lot numbers to confirm if your product is affected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1681-2022 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1681-2022 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.
