Open heart and vascular kits recalled over cracked anesthesia circuit tubing
Medline is recalling open heart supplement and vascular kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA 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 DYNJ909116D (OPEN HEART SUPPLEMENT) and DYNJ909124F (VASCULAR).
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 kits. The open heart supplement kit carries case UDI-DI 40198459055356 and each UDI-DI 10198459055355, lots 25FBM604 and 25GBP604. 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; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- 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 (4)
- DYNJ909116D UDI-DI 40198459055356 (case)
- 10198459055355 (ea) Lots 25FBM604 25GBP604
- DYNJ909124F UDI-DI 40198459130619 (case)
- 10198459130618 (ea) Lots 25FBB831 25GBI833
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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