Class IIReported 2026-01-21

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

Reason for Recall

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.

Recall Number

Z-1100-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-19

Reported

2026-01-21

Distribution

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.