FDA-Device2026-01-21Class IIPROCESSING DEFECT
ICU Medical Pulsator Arterial Blood Sampling Kit recalled for cracked syringe collar
OTHERNationwide distribution
Stop using ICU Medical Pulsator blood sampling kits
ICU Medical Inc. is recalling specific lots of Pulsator Arterial Blood Sampling Kits because some syringes have cracks in the collar. This crack can cause blood to leak during sampling, delays in blood draws, or the need to repeat the procedure.
- Check if your kit matches one of the affected lot numbers listed by ICU Medical (6141992, 6156228, 6141999, 6142000, 6147906, 6147907, 6131839, 6131838, 6142001, 6142002).
- Stop using affected kits immediately.
- Contact ICU Medical or your healthcare facility for instructions on obtaining replacement kits.
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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