Portex Spinal Tray, Item No. A3729-24 A3595
- Company
- Icu Medical Inc.
- Recall Initiated
- December 19, 2025
- Posted
- January 15, 2026
- Recall Number
- Z-1101-2026
- Quantity
- 64290 total
- Firm Location
- Minneapolis, MN
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.
Distribution
US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
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
Root Cause
Under Investigation by firm
Action Taken
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.