Device product
Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A
Z-2440-2026
Product summary
- Event
- Event 98951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,654 kits total
- Official record key
device-enforcement:Z-2440-2026
Official wording
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Code information: EBSI1688 UDI-DI 10653160370130 Lot 2025102890 EBSI1328A UDI-DI 10653160382980 Lot 2025103090
Distribution pattern: US Nationwide distribution. OUS distribution pending.
Derived failure modes
-
Unknown
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.