Z-2439-2026 Class II Ongoing
FDA device recall Z-2439-2026 was initiated by Medline Industries, LP on Apr 27, 2026 and is designated Class II. Reason for recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. The recall status is ongoing. Affected quantity: 49,654 kits total.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 24, 2026
- Initiation Date
- Apr 27, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49,654 kits total
Product Description
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
Reason for Recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Distribution Pattern
US Nationwide distribution. OUS distribution pending.
Code Information
ECVC6805B UDI-DI 10653160387428 Lot 2025120890 ECVC8055A UDI-DI 10653160387848 Lot 2025112690 ECVC6915A UDI-DI 10653160389439 Lot 2025102790 ECVC6985B UDI-DI 10653160388272 Lot 2025103190
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2439-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026