Portex Spinal Tray, Item No. A3729-24 A3595
Recall
- Recall Number
- Z-1101-2026
- Event Number
- 98168
- Firm
- ICU Medical Inc.
- FEI Number
- 3012307300
- Product Code
- CAZ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 19, 2025
- Posted
- January 15, 2026
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
Description
Portex Spinal Tray, Item No. A3729-24 A3595
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.
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.
US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
64290 total