Drug recall

Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change…

FDA recall event 96110 · Class II · MEDLINE INDUSTRIES, LP - Northfield

Key facts

Event ID 96110
Recall numbers Z-1040-2025, Z-1041-2025, Z-1042-2025
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
Product type Devices
Products Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray, Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray, Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Classification Class II
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden…
Initiation date Nov 18, 2024
Report date Feb 5, 2025
City Northfield
State IL
Country United States
FEI number 1417592

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

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