Medline Intubation Kits Recalled Due to Reduced Skin Barrier Wear
Medline is recalling 70 intubation convenience kits distributed in California and New York due to skin barrier components with reduced wear time that may lose effectiveness sooner than intended.
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: The recall involves a medical device component defect (reduced skin barrier wear time) where injury has not been reported, which fits the rubric criterion for High severity. While this is FDA Class II, it lacks the hospitalization reports needed for score 4.
Plain-English summary
Medline Industries is recalling 70 adult intubation convenience kits (Models DYNJAA254A and DYNJAA262A) distributed in California and New York. The kits contain skin barrier components with reduced wear time.
The skin barrier components have a shorter duration of effective adherence to and protection of skin before they need to be replaced, compared to the product's specifications. This reduced wear time could result in the barrier losing effectiveness sooner than intended.
Customers who received kits with lot numbers 24KBR956, 24LBA655, or 24LBD397 should check their inventory and contact Medline Industries for replacement or further guidance.
The recalled product
- Product
- Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- reduced-barrier-wear
- device-component-defect
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 (7)
- 1) DYNJAA254A
- UDI-DI 10195327686260 (each) 40195327686261 (case)
- Lot Number 24KBR956
- 24LBA655
- 2) DYNJAA262A
- UDI-DI 10195327208172 (each) 40195327208173 (case)
- Lot Number 24LBD397
Distribution
Distributed in 2 states:
- CA
- NY
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