FDA-Device2026-01-21Class II
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
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
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2026Don't want to check this manually?
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