Z-1052-2026 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-1052-2026 was initiated by Medline Industries, LP on November 26, 2025 and is designated Class II. Reason for recall: 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 ope… The recall status is ongoing. Affected quantity: 96 units.

Recall Details

Product Type
Devices
Report Date
January 21, 2026
Initiation Date
November 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96 units

Product Description

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution.

Code Information

Medline kit SKU DYNJ0785864R, UDI/DI 10195327656454 (EA) 40195327656455 (CA), Lot Number 25HMB184; Medline kit SKU DYNJ0792607R, UDI/DI 10198459503023 (EA) 40198459503024 (CA). Lot number 25JMH400.