FDA-Device2026-01-21Class IIPROCESSING DEFECT
ICU Medical Portex Spinal Tray syringes recalled for cracked collar risking blood leakage
What this means
Certain batches of syringes in ICU Medical's Portex Spinal Tray may have cracks in the syringe collar. This defect can prevent the syringe from working properly, cause repeated blood draws, or lead to blood leakage during arterial blood sampling or fluid delivery.
- Check if you have Portex Spinal Tray syringes (Item A3729-24 or A3595) with lot numbers 6146204 or 6157980.
- Stop using affected syringes immediately.
- Contact your supplier or ICU Medical for instructions on replacement or return.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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-1101-2026More ICU Medical recalls
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