FDA recall Z-1101-2026

ICU Medical Inc. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2025-12-19
Report date
2026-01-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2026