[pending] Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product descript
Pending LLM rewrite. Source: FDA_DEVICE Z-0442-2026.
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
- Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10
- 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 (20)
- DYNJAA0309A UDI-DI 40193489400268 (case)
- 10193489400267 (ea) Lots 25EBU353 25GBI473
- DYNJAA0360 UDI DI 40193489419000 (case)
- 10193489419009 (ea) Lots 25EBU304 25GBQ732
- DYNJAA0368A UDI-DI 40195327092550 (case)
- 10195327092559 (ea) Lots 25GBH582
- DYNJAA0380A UDI-DI 40195327478286 (case)
- 10195327478285 (ea) Lots 25FBB950 25FBT875 25GBX623
- DYNJAA0433 UDI-DI 40198459320706 (case)
- 10198459320705 (ea) Lots 25EBH621 25EBQ391
- DYNJAA10261B UDI- DI 40193489430784 (case)
- 10193489430783 (ea) Lots 25FBJ760
- DYNJAA10368A UDI-DI 40198459320720 (case)
- 10198459320729 (ea) Lots 25GBY374 25IBK072
- DYNJAA10392 UDI-DI 40888277962201 (case)
- 10888277962200 (ea) Lots 25FBN032
- DYNJAA10430A UDI-DI 40193489832052 (case)
- 10193489832051 (ea) Lots 25FBW335 25IBH048
- DYNJAA10547A UDI-DI 40193489603188 (case)
- 10193489603187 (ea) 25FBT853
Distribution
Distributed nationwide across the United States.
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