Surgical convenience kits recalled over cracked anesthesia circuit tubing
Medline is recalling 96,406 breast and hernia convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
The Medline Convenience Kit, BREAST HERNIA, DYNJ909125G, is being recalled.
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 recall covers 96,406 units from lots 25FBU543 and 25IBD459, carrying case UDI-DI 40198459130664 and each UDI-DI 10198459130663. 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
- Convenience Kit, BREAST HERNIA DYNJ909125G
- 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 (2)
- DYNJ909125G UDI-DI 40198459130664 (case)
- 10198459130663 (ea) Lot 25FBU543 25IBD459
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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