Device product
Portex Spinal Tray, Item No. A3729-24 A3595
Z-1101-2026
Product summary
- Firm
- ICU Medical Inc.
- Event
- Event 98168
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 64290 total
- Official record key
device-enforcement:Z-1101-2026
Official wording
Reason: 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.
Code information: 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Distribution pattern: US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
Derived failure modes
-
Unknown
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.