Device product
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Z-1100-2026
Product summary
- Firm
- ICU Medical Inc.
- Event
- Event 98168
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 64290 total
- Official record key
device-enforcement:Z-1100-2026
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. 4044EG-1 UDI-DI 30351688073062 Lots 6141992 6156228 2. 4080P-2 UDI-DI 30351688006176 Lots 6141999 6142000 6147906 3. 4084P-1 UDI-DI 30351688029540 Lots 6147907 (corrected 1/22/26, removed "-LSM" suffix) 4. 4080PE UDI-DI 30351688039150 Lot 6131839 5. 4080PG UDI-DI 30351688081173 Lots 6131838 6142001 6142002
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.