FDAHealthDecember 19, 2025
ICU Medical Inc. — 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2025
US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
What's affected?
- Product
- Portex Spinal Tray, Item No. A3729-24 A3595
- Brand
- ICU Medical Inc.
- Lot code
- 6146204
Additional details
1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 64290 total.
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