[pending] BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Pending LLM rewrite. Source: FDA_DEVICE Z-0907-2026.
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
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
The recalled product
- Product
- BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
- Manufacturer
- C.R. Bard 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)
- Lot# NGJU4327/UDI:(01)00801741015786
Distribution
Distributed nationwide across the United States.
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