← FDA ENFORCEMENT
Z-2439-2026Class II

Medline Industries, LP

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-06-24
Distribution
US Nationwide distribution. OUS distribution pending.
Firm state
IL
Product quantity
49,654 kits total
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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.

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

Code / lot info

ECVC6805B UDI-DI 10653160387428 Lot 2025120890 ECVC8055A UDI-DI 10653160387848 Lot 2025112690 ECVC6915A UDI-DI 10653160389439 Lot 2025102790 ECVC6985B UDI-DI 10653160388272 Lot 2025103190

Other recalls SPEQ maps to Risk Management & CAPA
2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.
See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.