Z-1101-2026 Class II Ongoing

Recalled by ICU Medical Inc. — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
January 21, 2026
Initiation Date
December 19, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
64290 total

Product Description

Portex Spinal Tray, Item No. A3729-24 A3595

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 Pattern

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

Code Information

1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980