FDA Medical devices recall ·
Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM… recall
- Recall number
- Z-2439-2026
- Date
- (initiated April 27, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 49,654 kits total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B
Why was it recalled?
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
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
ECVC6805B UDI-DI 10653160387428 Lot 2025120890 ECVC8055A UDI-DI 10653160387848 Lot 2025112690 ECVC6915A UDI-DI 10653160389439 Lot 2025102790 ECVC6985B UDI-DI 10653160388272 Lot 2025103190
Distribution
US Nationwide distribution. OUS distribution pending.
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-2439-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.