FDA Enforcement
Class II
Ongoing
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Recall: Z-1054-2026
·
Reported January 21, 2026
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Enforcement
- Recall Number
- Z-1054-2026
- Event ID
- 98154
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 21, 2026
- Initiation Date
- November 26, 2025
- Classification Date
- January 12, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Reason
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Code Info
UDI/DI 10193489587869 (EA) 40193489587860 (CS), Lot Number 25HBQ850
Distribution
US Nationwide distribution.
Quantity
16 units