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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: 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.

Z-1060-2026

November 26, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98154
Status
Ongoing
Classification
Class II
Quantity
338 units
Official record key
device-enforcement:Z-1060-2026

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: Medline 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.

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.