[pending] Vortex Surgical I2 Injection Kit, VS0500
Pending LLM rewrite. Source: FDA_DEVICE Z-1252-2026.
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
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
The recalled product
- Product
- Vortex Surgical I2 Injection Kit, VS0500
- Manufacturer
- Vortex Surgical 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 (1)
- Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
Distribution
Distributed nationwide across the United States.
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