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Recall Observatory FDA recall evidence

Device product

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B

Z-1053-2026

November 26, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98154
Status
Ongoing
Classification
Class II
Quantity
33 units
Official record key
device-enforcement:Z-1053-2026

Official wording

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 information: UDI/DI 10195327634698 (EA) 40195327634699 (CS), Lot numbers: 25HLA435, 25HLB046.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.