Home/Recalls/FDA-Z-1058-2026
FDA DevicesClass II

Medline Kits containing B. Braun IV Administration Sets and Pump Administration ...

Published: January 21, 2026Recall ID: Z-1058-2026Category: devicesCountry: US

Reason for Recall / Hazard

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.

Product Description & Identification

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.

Affected Products

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.

Additional Source Details

FieldValue
CityNorthfield
StateIL
Event id98154
Address 13 Lakes Dr
Code infoMedline kit SKU DYKS1339B, UDI/DI 10195327386726(EA) 40195327386727 (CS) , Lot Number 25HMC849; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25IMG807; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25JMF937; Medline kit SKU DYKS1359B, UDI/DI 10195327566449(EA) 40195327566440 (CS) , Lot Number 25JMD518; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25HMD322; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25JMG543.
Postal code60093-2753
Report date20260121
Product typeDevices
Product quantity1725 units
Reason for recallMedline 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251126
Initial firm notificationLetter
Center classification date20260112

Overview

  • Recalling FirmMedline Industries, LP
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide distribution.
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