[pending] Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP
Pending LLM rewrite. Source: FDA_DEVICE Z-0448-2026.
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
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
The recalled product
- Product
- Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
- Manufacturer
- Medline Industries, LP
- 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 (8)
- HIP PINNING DYNJ909308D UDI-DI 40198459055288 (case)
- 10198459055287 (ea) Lots 25FBB311 25GBC282 25GBW486
- ORTHO SPINE ST CLAIR DYNJ901048N UDI-DI 40198459055554 (case)
- 10198459055553 (ea) Lots 25GBQ070
- SET UP DYNJ909132F UDI-DI 40198459130572 (case)
- 10198459130571 (ea) Lots 25GBI845 25IBF708
- UROLOGY MINOR DYNJ909123F UDI-DI 40198459130602 (case)
- 10198459130601 (ea) Lots 25GBT826 25IBF707
Distribution
Distributed nationwide across the United States.
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