Home/Recalls/FDA-Z-1060-2026
FDA DevicesClass II

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

Published: January 21, 2026Recall ID: Z-1060-2026Category: 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) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.

Affected Products

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.

Additional Source Details

FieldValue
CityNorthfield
StateIL
Event id98154
Address 13 Lakes Dr
Code infoMedline kit SKU DYNJ0395085V,UDI/DI 10198459313745 (EA) 40198459313746 (CS), Lot Number 25HMC337; Medline kit SKU DYNJ66311C,UDI/DI 10198459364556 (EA) 40198459364557 (CS), Lot Number 25KBG419; Medline kit SKU DYNJ86770,UDI/DI 10195327674229 (EA) 40195327674220 (CS), Lot Number 25IBU284; Medline kit SKU DYNJ86770,UDI/DI 10195327674229 (EA) 40195327674220 (CS), Lot Number 25KBJ623; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25HBU964; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25IBV819; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25KBF028.
Postal code60093-2753
Report date20260121
Product typeDevices
Product quantity338 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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