—#217766

Product

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

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K952516
Affected lot / 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On December 19. 2025, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that affected lots may have a crack present on the syringe collar. Customers were instructed to discontinue use of affected lots, and to destroy products following their institution's process for destruction. If destruction is not immediately possible, affected product should be quarantined until disposal.

Recalling firm

Firm: ICU Medical Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

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

Timeline

Recall initiated: 2025-12-19
Posted by FDA: 2026-01-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217766. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.