Urology and hip pinning kits recalled over cracked anesthesia circuit tubing
Medline is recalling ortho spine, urology minor, set up and hip pinning convenience kits after complaints of anesthesia circuit leaks from cracked 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
Medline convenience kits DYNJ901048N (ORTHO SPINE ST CLAIR), DYNJ909123F (UROLOGY MINOR), DYNJ909132F (SET UP) and DYNJ909308D (HIP PINNING) are 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 action covers 96,406 total units across the affected kits. The hip pinning kit carries case UDI-DI 40198459055288 and each UDI-DI 10198459055287, lots 25FBB311, 25GBC282 and 25GBW486. 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 Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
- 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 (8)
- HIP PINNING DYNJ909308D UDI-DI 40198459055288 (case)
- 10198459055287 (ea) Lots 25FBB311 25GBC282 25GBW486
- ORTHO SPINE ST CLAIR DYNJ901048N UDI-DI 40198459055554 (case)
- 10198459055553 (ea) Lots 25GBQ070
- SET UP DYNJ909132F UDI-DI 40198459130572 (case)
- 10198459130571 (ea) Lots 25GBI845 25IBF708
- UROLOGY MINOR DYNJ909123F UDI-DI 40198459130602 (case)
- 10198459130601 (ea) Lots 25GBT826 25IBF707
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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