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Recall Observatory FDA recall evidence

Device product

Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837

Z-2438-2026

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-2438-2026

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: EBSI1705A UDI-DI 10653160382850 Lot 2025103090 EBSI1057A UDI-DI 10653160356875 Lot 2025120890 EBSI1498 UDI-DI 10193489111538 Lot 2025110690 EBSI1585 UDI-DI 10653160354796 Lot 2025102190 EBSI1621 UDI-DI 10653160358336 Lot 2025110390 EBSI1837 UDI-DI 10653160388555 Lot 2025102990

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.