Z-2437-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- April 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49,654 kits total
Product Description
Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER MAINTENANCE KIT DT17570 DIALYSIS DRESSING CHANGE KIT DT21370B DRESSING CHANGE TRAY - GOLD DT21115B PORT DRESSING CHANGE KIT DYNDC2815A
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
DYNDC2356B UDI-DI 10653160327271 Lot 2025102090 DT17570 UDI-DI 10653160266891 Lot 2025102290 DT21370B UDI-DI 10653160360643 Lot 2025102290 DT21115B UDI-DI 10653160360681 Lot 2025111490 DYNDC2815A UDI-DI 10653160357070 Lot 2025110590