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Recall Observatory FDA recall evidence

Device product

Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P

Z-2446-2026

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-2446-2026

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: CDS985505G UDI-DI 10195327412555 Lot 26AMC363 DYNJ68260D UDI-DI 10195327506513 Lot 25KBE168 DYNJ905094B UDI-DI 10193489858174 Lot 25KMB136 CDS820091P UDI-DI 10195327403539 Lots 26BBO404 26CBN891

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.