FDA Medical devices recall ·
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB… recall
- Recall number
- Z-1183-2025
- Date
- (initiated January 9, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 0 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Why was it recalled?
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) ACC010809, UDI-DI 10198459012235 (each) 40198459012236 (case), Lot Number 24JDC400; 2) ACC010813, UDI-DI 10198459012556 (each) 40198459012557 (case), Lot Number 24KDA437
Distribution
US States: CA, NY
States: California New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1183-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.