[pending] Portex Spinal Tray, Item No. A3729-24 A3595
Pending LLM rewrite. Source: FDA_DEVICE Z-1101-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Portex Spinal Tray, Item No. A3729-24 A3595
- Manufacturer
- ICU Medical Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26
- removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Distribution
Distributed nationwide across the United States.
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