—#217767

Product

Portex Spinal Tray, Item No. A3729-24 A3595

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K965017
Affected lot / code info: 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980

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 #217767. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.