Medline Respiratory Intubation Kits Recalled for Reduced Skin Barrier Wear
Medline is recalling respiratory intubation convenience kits because skin barrier components wear out faster than designed. Affected kits may require more frequent replacement than expected.
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: FDA Class II medical device recall with documented component defect (reduced skin barrier wear time) but no reported injuries or hospitalizations. Classified as a risk-of-harm product per the rubric, since premature barrier failure could result in skin damage or infection in vulnerable patients.
Plain-English summary
Medline Industries is recalling specific respiratory intubation convenience kits due to reports of reduced skin barrier wear time. The affected kits contain components that do not maintain their adhesive properties or protective function as long as intended, requiring earlier replacement than normal.
The recall affects Medline Convenience Kits for Various Procedures in two models: CLOVIS RESP/INTUB DRAWER 2 (Model ACC010809, Lot 24JDC400) and RESP/INTUBATION DRAWER #2 (Model ACC010813, Lot 24KDA437). These kits have been distributed in California and New York.
Healthcare facilities and patients using these kits should verify whether they have the affected lot numbers. If the affected products are in use, they should be replaced with verified alternatives to ensure adequate skin barrier protection during respiratory and intubation procedures.
The recalled product
- Product
- Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- skin-barrier-failure
- reduced-durability
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 (6)
- 1) ACC010809
- UDI-DI 10198459012235 (each) 40198459012236 (case)
- Lot Number 24JDC400
- 2) ACC010813
- UDI-DI 10198459012556 (each) 40198459012557 (case)
- Lot Number 24KDA437
Distribution
Distributed in 2 states:
- CA
- NY
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