Adult intubation trays recalled over a smaller catheter packed inside
Medline is recalling 130 Adult Intubation Trays because an 8 Fr suction catheter may have been packed in place of the required 14 Fr catheter.
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: Scored 3 under the risk-of-harm criterion: the firm states the wrong catheter size may result in hypoxia or respiratory failure from airway obstruction, and no injuries are reported.
Plain-English summary
The Intubation Tray (Adult) containing Suction Catheter Kits, SKU DYNJAA245B, is being recalled by Medline Industries, LP.
The record states a smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. The record states use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction, and that airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death.
The record lists 130 units under kit lots 25IBC172 and 25HBJ413, UDI 10198459480317 (each) and 40198459480318 (case). Distribution was nationwide in the US and Canada. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected trays and follow Medline's instructions, checking catheter size before use.
The recalled product
- Product
- Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Respiratory kit
- Affected units
- 130
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 (1)
- Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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