ICU Medical recalled 64,290 Pulsator Arterial Blood Sampling Kits due to a potential crack in the syringe collar. This defect may cause blood leakage and delayed sampling. The recall affects models sold nationwide since December 2025.
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall involves ICU Medical's Pulsator Arterial Blood Sampling Kit, specifically item numbers 4044EG-1, 4080P-2, 4084P-1, 4080PE, and 4080PG. The kits were distributed across various states including California, Florida, and Texas.
Affected syringes may have a crack in the collar, which could lead to delayed blood draws or fluid delivery. This defect poses a risk of blood leakage during arterial sampling.
There have been no reported injuries or deaths associated with this recall. The potential for leakage during use remains a significant concern.
Stop using the affected devices immediately. Contact ICU Medical Inc. or your healthcare provider for further instructions and follow the recall process outlined in the notification letter.
For more information, contact ICU Medical Inc. or visit the FDA's recall page at the provided link. The company is actively notifying customers about the recall.
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