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FDA (Device enforcement)Recalled 2025-12-19class ii

ICU Medical Inc.: Portex Spinal Tray, Item No. A3729-24 A3595

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA. Quantity: 64290 total Lot/code info: 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980

UPC codes

30351688075691, 35019517108211

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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