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Medline Industries, LP: Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYN

Medical DevicesSource: FDA (device) · Date: 2026-02-04

Read the official notice at FDA (device) →

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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 medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.
Reason / hazard
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-12-12
Code info
Medline Kit SKU DYNJ0660040R: UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Number 25KMG652; Medline Kit SKU DYNJ39225K: UDI/DI 10198459102257 (EA) 40198459102258 (CS), Lot Number 25JMJ958; Medline Kit SKU DYNJ39225K: UDI/DI 10198459102257 (EA) 40198459102258 (CS), Lot Number 25KMJ566; Medline Kit SKU DYNJ46620I: UDI/DI 10198459404009 (EA) 40198459404000 (CS), Lot Number 25KBE927; Medline Kit SKU DYNJ59250I: UDI/DI 10198459359941 (EA) 40198459359942 (CS), Lot Number 25KMB767; Medline Kit SKU DYNJ65980J: UDI/DI 10198459423727 (EA) 40198459423728 (CS), Lot Number 25KMJ630; Medline Kit SKU DYNJ68288A: UDI/DI 10195327056995 (EA) 40195327056996 (CS), Lot Number 25KMF183; Medline Kit SKU MNS13035: UDI/DI 10653160990482 (EA) 40653160990483 (CS), Lot Number 25KME754; Medline Kit SKU PHS41746D: UDI/DI 10198459438820 (EA) 40198459438821 (CS), Lot Number 25KMD226.
Product quantity
66 units
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98226
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