Medline Industries, LP: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D
- Reason / hazard
- 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;
- Recall initiated
- 2025-10-10
- Code info
- ENT DYNJ909128I UDI-DI 40198459333355 (case), 10198459333354 (ea) Lots 25GBO685; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D UDI-DI 40198459055301 (case), 10198459055300 (ea) Lots 25GBN602
- Product quantity
- 96,406 total units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 97882
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