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Medline Industries, LP: Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A

Medical DevicesSource: FDA (device) · Date: 2026-09-30

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Reason / hazard
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2026-08-10
Code info
1) DYNJ81325A, UDI-DI: 10195327270360(each), 40195327270361(case), Lot Number: 23HBB258
Product quantity
128 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
99739
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