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 Pulsator Arterial Blood Sampling Kit is used for drawing arterial blood and delivering fluids in medical settings. Healthcare providers rely on these kits for accurate blood sampling during various procedures.
A crack in the syringe collar can disrupt the integrity of the syringe, leading to potential blood leakage during use. This defect poses risks for both patients and healthcare providers.
This recall is not part of a broader industry pattern.
The recall poses an urgent issue for healthcare providers relying on these kits for patient care, risking inconvenience and potential safety hazards.
You can find the item number on the packaging and the syringes themselves. The UDI-DI numbers are also listed in the recall information.
Expect a realistic timeline of 4-6 weeks for refund processing after returning the product.
Keep copies of your recall notification letter, any correspondence with ICU Medical, and receipts related to your purchase.
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.
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