FDA-Device2026-01-21Class II

Portex Spinal Tray, Item No. A3729-24 A3595

ICU Medical Inc.
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.

Sold states
US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
Affected count
64290 total
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
Portex Spinal Tray, Item No. A3729-24 A3595

Official notice

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

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