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Recall Observatory FDA recall evidence

Device product

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

Z-2437-2026

April 27, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98951
Status
Ongoing
Classification
Class II
Quantity
49,654 kits total
Official record key
device-enforcement:Z-2437-2026

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: 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

Distribution pattern: US Nationwide distribution. OUS distribution pending.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.