[pending] Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
Pending LLM rewrite. Source: FDA_DEVICE Z-0450-2026.
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; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
- 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 (4)
- GYN ROBOTIC DYNJ901046M UDI-DI 40198459130381 (case)
- 10198459130380 (ea) Lots 25FBM810 25GBK307
- ROBOTIC PROSTATE DYNJ909120D UDI-DI 40198459130541 (case)
- 10198459130540 (ea) Lots 25GBT821 25IBF809
Distribution
Distributed nationwide across the United States.
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