Adult anesthesia circuit kits recalled over cracked expandable tubing
Medline is recalling multiple adult 120-inch expandable anesthesia circuits after complaints of leaks caused by cracks in the tubing. The FDA has classified it Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
Medline anesthesia circuit kits and other kits containing anesthesia circuits are being recalled, including ADULT 120 EXPANDABLE W/MASK (DYNJAA10591), ANES CIRC 120IN EXP-LF (DYNJAA6555G) and ANES CIRCUIT ADULT 120 IN-LF (DYNJAA10817).
The firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120 inch expandable tubing. Medline states that cracks and resulting leaks may lead to hypoxia, hypoventilation and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death, and that volatile anesthetics may also escape into the operating room environment.
The action covers 96,406 total units across the affected products, with identifiers including case UDI-DI 40193489400268 and each UDI-DI 10193489400267 for DYNJAA0309A, lots 25EBU353 and 25GBI473. Distribution was nationwide in the United States and internationally to Mexico and Panama. The FDA has classified the recall as Class I, its most serious category.
Facilities should quarantine affected lots immediately and follow Medline's instructions.
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…
- Manufacturer
- Medline Industries, LP
- Affected units
- 96,406
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
Part of a larger recall action
This product is one of 10 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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